Sr. Manager Regulatory Affairs, Advertising & Promotion (Remote)

Regeneron Pharmaceuticals; Oregon; Hybrid; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager in Regulatory Affairs, Advertising and Promotion. This remote US-based role leads regulatory activities for advertising and promotion of marketed products and pipeline programs, with minimal guidance from the Director, ensuring compliance and corporate integrity.

You will creatively advise on product messages, review US and global materials, collaborate with Marketing, Medical Affairs and Legal, manage FDA OPDP interactions, and help shape

Qualifications

• Minimum 3–4 years in regulatory affairs, preferably advertising and promotion.
• Bachelor's degree in Life Sciences required; advanced degree preferred.
• Regulatory knowledge in pharma marketing regulations and guidance.
• Experience with FDA interactions and promotional material reviews.

Responsibilities

• Manage US and global regulatory activities for advertising and promotion of marketed and pipeline products.
• Advise on development of product messages across multiple functions.
• Provide regulatory guidance to Commercial teams, Medical Affairs, and Legal for conference exhibits, disease awareness, and speaker programs.
• Review US and Global product and disease state materials to ensure compliance and alignment with company goals.
• Collaborate with Marketing, Medical Affairs, and Legal to ensure timely, compliant promotion.
• Lead communications with regulatory advertising and promotion professionals at partner companies.
• Support FDA OPDP interactions and submissions, maintaining effective relationships with reviewers.
• Monitor regulatory environment for evolving promotional requirements and enforcement actions.
• Contribute to process improvements for promotional review and standardization.

Skills

Regulatory affairs

Advertising and promotion

FDA OPDP

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity.

When & where:

• Work Location: Remote - United States
• 5 days per week - Remote

Discover your role:

• Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company's marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support company goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co‑promote partner companies
• Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
• With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role requires:

• A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
• At minimum, a Bachelor's degree from an accredited College or University in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements.
• Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
• Experience with pharmaceutical products required, biologics experience is a plus
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
• Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
• Ability to influence cross-functional teams and interact with senior management

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centres, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit . For other locations, additional information will be provided during the recruitment process.

Salary Range (annually) $150,500.00 - $245,500.00