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At Catawiki, every day brings the extraordinary! Whether it’s Daniel Ricciardo’s Formula 1 Car, a Woolly Mammoth’s Skeleton, Lady Gaga’s Jumpsuit or Usain Bolt’s running shoe, we encounter exceptional objects every day.

We’re a one-of-a-kind marketplace for buying and selling special objects. Each week, more than 100,000 unique items are auctioned, all carefully curated by our passionate in-house experts.

Having sold over 25 million unique objects, our mission is to become the world’s most popular destination for special objects. As a growing, diverse and sustainable scale-up, we proudly live by three core values. If these values resonate with you, we’d love to explore how you can join us.

• Taking ownership and driving impact
• Being open to change and feedback
• Being passionate about our mission and our customers.

The role

As a Trainee/Paralegal, you will be an important part of the Catawiki legal team and as such support the international business in its ambitious growth targets. You are passionate about providing support to legal counsels at the best possible level. As you will be involved in a very wide range of legal projects, this role will give you the opportunity to see, practice, and learn a lot. The legal fields include commercial law, consumer law, contract law, compliance, privacy, data protection, corporate law, sustainability/ESG and last but not least artificial intelligence. No day is like the other - The work is varied, the business is dynamic, so each day is a new challenge!

This is a role for a traineeship with a fixed term of 6 months in which you will get the opportunity to grow and help a wide range of people and as such you know how to relate to people in a variety of situations because you are a team player, highly trustworthy, discrete, pragmatic and make use of your good judgement.

Within and outside your circle of influence you are expected to proactively come up with solutions, plans, and ideas that enable the legal team to achieve its ambitious goals.

The Catawiki legal team is based at the company headquarter in Amsterdam. We use a hybrid work schedule, with on average two office days a week (Tuesday & Thursday).

Results and Responsibilities

• Supporting legal operations and maintaining the case management system
• Support in the further development of the contract management system and any other legal or compliance tooling
• Drafting internal memos on specific relevant legal, regulatory or compliance topics
• Monitoring and reporting on several legal dashboard(s)
• Reviewing and addressing legal questions raised by other departments
• Taking notes during regular project meetings and sharing them afterwards, keeping track of deadlines and deliverables
• Prepare simple training materials and legal guidelines for our business stakeholders, with support of the legal counsels
• Further develop and update the Legal Knowledge Hub, including links to templates, guidelines, do’s & don’ts; and updating current content in alignment with the legal counsels

Tasks and Activities

• Support the legal counsels in their daily tasks
• Dealing with the review of standard agreement such as NDA’s and commercial contracts
• Contract and litigation administration management
• Ensure further professionalism of the department by inventorying, implementing and optimising tools, documents and processes
• Understand improvement needs and provide support to team members
• Communicate expectations to your team and provide timely updates
• You are actively seeking and driving collaboration with other teams and other departments
• You are proactively liaising with (international) stakeholders and colleagues at Catawiki
• Support corporate housekeeping by coordinating that documents are duly signed, apostilled and notarized in a timely manner
• Compilation and implementation of a wide variety of legal documents and agreements
• Provide assistance in helping to resolve legal matters as requested

Requirements

• Enrolled in a Dutch University for the whole duration of the next academic year
• Thesis writing is not supported during the initial six-month period, but may be an option upon contract extension
• This is a traineeship with a non-negotiable minimum duration of 6 months, preferably 1 year but not mandatory
• Certification or associate’s degree in law (bachelor’s degree is preferred) (or final stage)
• Tech savvy
• Experience in preparing and reviewing legal documents
• “Can do” and “hands on” mentality
• Team player
• Strong organisational and communication skills
• Fluency in English, preferred fluency in Dutch (proficiency in any other language is a plus)
• Residency in the Netherlands and able to go to our Amsterdam office twice per week

Why You’ll Love Working with Us

• Create a visible impact by working at scale in a global organisation serving millions of customers across 80+ categories. In our flat structure, every role has a broad scope and directly impacts both our customers and the business.
• Learn and grow through our Learning & Development initiatives, including clear development plans and mentorship programmes to support your career progression.
• A culture of connection defines us. We’re a passionate, diverse team of 800+ Catawikians representing 60+ nationalities. We foster an inclusive and queer-friendly environment where everyone is encouraged to bring their full self to work.
• Celebrate life’s moments with us. You’ll receive a €100 Catavoucher when you join, a €50 Catavoucher on your birthday, and an extra day off each year to “Pursue Your Passion ”. We also offer additional leave for key work anniversaries and important life events. Benefits may vary by location.

Our Offices and Way of Working

Our vibrant offices in Amsterdam and Lisbon are designed to inspire collaboration. Most Catawikians operate in a hybrid setup, combining office-based and remote work, with a minimum of two days per week in the office, unless a role is explicitly stated as fully remote or fully office-based.

Interested?

Apply with an English CV and Cover Letter. By applying, you agree to Catawiki’s Applicant Privacy Policy. If you’re excited about this role but don’t meet every requirement, we still encourage you to apply anyway. You may be just the right candidate for this or other roles.

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, International Medical Affairs, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally.

Responsibilities:

• Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate) and plans strategically for overall system of regulatory communications. Provides functional input on key initiatives impacting other areas. Leads the implementation of risk management strategies and risk management plans for global Regulatory advertising and promotion.
• Provides global regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/business partners. Maintains current knowledge of global codes of practice, regulations and guidance’s that impact pharmaceutical advertising and promotion. Has direct international (ex-US) accountability for assigned therapeutic areas within the Regulatory Advertising and Promotion department.
• Implements department policies and procedures and significantly contributes to the development and updates to Divisional and Corporate policies effecting global core messaging. Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans. Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
• Provides critical analysis and potential interpretations of the regulatory position and messaging for communications in response to often highly visible pharmaceutical news having political, financial and legal interests. Creates an environment to attract, retain, empower and mentor leaders in business knowledge, management skills, and continued development. Provides strategic input into comprehensive training program. Negotiates/resolves the majority of decisions with Marketing, Medical, Legal, Public Affairs, and compliance counterparts.
• Collaborates and communicates effectively through all levels of management across multiple divisions and functions. Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and promotion. Apply novel and creative methods to problem solving. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations.
• Balances business needs and risk assessments with creative decision-making abilities. Responsible for assigned marketed and development compounds advertising and promotion strategies. Has accountability for: the sound representation of global Regulatory Advertising and Promotion position within and external to AbbVie; and the operations, initiatives, and strategies for the regulatory Advertising and Promotion department.
• Leads cross-functional/ multidisciplinary/therapeutic teams Demonstrates compliance with international codes of practice relevant regulations and manages financial business goals.
• This role is required to work a hybrid work schedule-3 days in office from our AbbVie Mettawa, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required. Master’s, Ph.D or Pharm D preferred.
• You should also possess:
  • Associate Director: 8+ years of pharmaceutical experience with a Bachelor’s, 5+ years with a Pharm D plus relevant ad promo experience
• The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
• International experience desired but not required

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
• Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie
• Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
• Development and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organizations without damage to relationships
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
• This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

• Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Facilitates team reviews.
• Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
• Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
• Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
• Position accountability/scope:
  • Some supervision required
  • Receives project assignments from manager but has responsibility for managing own projects with some oversight
  • Reviews project progress with manager on a regular basis with direction provided by manager
  • Trains, and mentors less experienced staff.
• This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie North Chicago, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Required Education: Bachelor’s degree.
  • Note: Years of experience may also compensate for lower education.
  • Preferred Education: PMP and RAC certificates a plus
• Required Experience: Four years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• Preferred Experience:
  • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
  • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
  • Proven leadership skills and presence
  • NOTE: Higher education may compensate for years of experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to  participate in our short-term incentive programs.  ​

Note: No amount of pay is  considered to be wages or compensation until such amount is earned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Company’s sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolute discretion,  consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
• Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie
• Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
• Development and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organizations without damage to relationships
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
• This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission

projects involving multiple cross-functional regulatory submission teams. With input from the submission

teams, this individual establishes and maintains submission content planners and associated timelines,

facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with

publishing vendor, and fulfills Submission Management functions on Project Teams in support of

Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized

as a discipline expert and resource in regulatory affairs submission management.

Responsibilities:

• Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverables.
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support. Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.  Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
• Actively contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.
• Position accountability/scope: o
  • Minimal supervision required o Receives project assignments from manager but has responsibility for managing own projects.
  • Reviews project progress with manager on a regular basis with direction provided on follow-up.
  • Provides estimates of activities with budgetary impact.
  • Trains, mentors and may supervise the work of less experienced staff.
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Required Education: Bachelor’s degree.
  • Note: Years of experience may also compensate for lower education.
  • Preferred Education: PMP and RAC certificates a plus
• Required Experience: 6 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat. One to two years in cross functional project management.
• Preferred Experience:
  • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
  • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
  • Proven leadership skills and presence
  • NOTE: Higher education may compensate for years of experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
• Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie
• Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
• Development and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organizations without damage to relationships
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
• This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

The work we do has an impact on millions of lives, and you can be a part of it.

We help protect our customers against life’s uncertainties. Regardless of where you work within the company, you’ll be helping provide protection and peace of mind when our customers need it most.

Basic Purpose and Objective of the Position:

This professional officer role is designed for a licensed attorney with substantial legal experience in commercial mortgage lending and related legal matters. The position is responsible for providing and managing legal support for the Company’s investment activities, including the review and drafting of loan commitments, the closing of new mortgage loans, compliance with regulatory requirements, and ongoing legal administration of the investment portfolio. The incumbent should have significant experience, typically five or more years, in commercial real estate lending and/or private practice with a specialization in this area. A strong commitment to quality, responsiveness, and customer service is essential to maintaining and strengthening long-term business relationships.

Key Responsibilities

•    New Mortgage Loan Closings. Ensure the Company’s mortgage loan investments are safeguarded through the preparation, review, analysis, negotiation and modification of the legal documents securing its investments.

•    Perform all legal work associated with the closing of the Company’s commercial mortgage loans including: drafting, negotiation and review of loan commitments, loan documents and other legal documents; review title commitments, survey and title policies for property serving as collateral; review due diligence materials to insure compliance with loan commitment requirements; and coordinate with outside counsel in all aspects of closing the Company’s loan commitments for commercial mortgage loans

•    Portfolio Maintenance. Ensure proper maintenance of the Company’s loan portfolio by providing timely legal documentation of changes to portfolio loans or the properties securing them (e.g. partial releases, consents to easements, replatting, loan modifications and loan assumptions).

•    Serve as Legal Advisor. Support and facilitate the decision-making process in the Investment Department. Act as legal advisor to the department. Assist and advise in development of policies and procedures to respond to regulatory and legislative requirements imposed as the Company and its investments

•    Manage and train one or more legal support staff (i.e. legal secretaries, legal assistants and paralegals).

•    Other Job Duties as assigned by senior management.

Knowledge/Experience/Education/Training:

•    This position requires an attorney with 5+ years of negotiating and legal drafting skills equivalent to a partner at a major law firm. A breadth of industry knowledge and contacts (both legal and business) are essential.

Abilities:

•    The incumbent will need meticulous attention to detail and negotiating stamina to protect and ensure the quality of the Company’s investments, but must couple those abilities with an attitude of building positive customer experiences and relationships.

Contact with others.

•    Must have strong negotiating skills coupled with a firm commitment to customer service and development of long-term business relationships. At least 50% of the incumbent’s time is spent in communication with outside customers, mortgage banker and brokers and counsel for the parties to the mortgage transactions.

•    The incumbent must be proactive and creative in finding legal solutions for the business and competitive needs of the Company, particularly relating to creative investment opportunities (e.g the participating loan program, loan pools, new real estate ownership and lending models).

$95,500 - $140,000 a year

Protective’s targeted salary range for this position is $95,500 to $140,000. Actual salaries may vary depending on factors, including but not limited to, job location, skills, and experience. The range listed is just one component of Protective’s total compensation package for employees.

This position also offers additional incentive opportunities through an annual incentive based on individual and Company performance.

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Employee Benefits:

We aim to protect the wellbeing of our employees and their families with a broad benefits offering. In addition to offering comprehensive health, dental and vision insurance, we support emotional wellbeing through mental health benefits and an employee assistance program. Work/life balance is important and Protective offers a variety of paid time away benefits (e.g., paid time off, paid parental leave, short-term disability, and a cultural observance day). The financial health of our employees is just as important as physical and emotional health.  Some of the financial wellbeing benefits include contributions to healthcare accounts, a pension plan, and a 401(k) plan with Company matching. All employees are encouraged to protect their overall wellbeing by engaging in ProHealth Rewards, Protective’s platform to improve wellbeing while earning cash rewards.

Eligibility for certain benefits may vary by position in accordance with the terms of the Company’s benefit plans.

Accommodations for Applicants with a Disability:

If you require an accommodation to complete the application and recruitment process due to a disability, please email [email protected]. This information will be held in confidence and used only to determine an appropriate accommodation for the application and recruitment process.

Please note that the above email is solely for individuals with disabilities requesting an accommodation.  General employment questions should not be sent through this process.

We are proud to be an equal opportunity employer committed to being inclusive and attracting, retaining, and growing an inclusive workforce.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.