Sr. Manager Regulatory Affairs, Advertising & Promotion (Remote)
About The Position
Regeneron is seeking a Senior Manager to join its Regulatory Affairs Advertising and Promotion team. The role applies clinical development knowledge and expertise in advertising and promotion regulations and guidance to the development of product messages for Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). With minimal guidance from the Regulatory Affairs, Advertising and Promotion Director, the Senior Manager oversees therapeutic areas and translates product messages into advertising and promotion initiatives that support commercial objectives while maintaining compliance and corporate integrity. The position manages US and, where applicable, global regulatory activities for advertising and promotion of marketed products and commercial development of pipeline products. It provides regulatory advice to Commercial teams and Medical Affairs, reviews product and disease-state communications, supports interactions with FDA's Office of Prescription Drug Promotion (OPDP), and collaborates with Marketing, Medical Affairs, Legal, regulatory therapeutic area leads, and co-promote partners. The role also contributes to marketing application documents, study reports, labeling development, and process improvements.
Requirements
- A minimum of 3 to 4 years of experience in regulatory affairs, preferably in advertising and promotion.
- At least a bachelor's degree from an accredited college or university in life sciences; regulatory experience may offset education requirements.
- Advanced knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with a focus on advertising and promotion.
- Experience with pharmaceutical products.
- Ability to review promotional materials, interact with FDA OPDP/APLB, and manage launch products or campaigns.
- Excellent written and verbal communication skills for providing strategic regulatory advice.
- Ability to influence cross-functional teams and interact with senior management.
Nice To Haves
- Advanced degree (Master's, PharmD, Ph.D., MD, or DO) in medicine or science.
- Biologics experience.
- Experience working directly or indirectly with FDA, particularly OPDP/APLB.
- Ability to support global promotional review.
- Understanding of clinical trial recruitment materials.
- Familiarity with labeling regulations.
Responsibilities
- Manage US and, where applicable, global regulatory activities related to advertising and promotion for marketed products and commercial development of pipeline products.
- Advise on development of product messages and materials across multiple functional areas.
- Provide regulatory guidance to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness, and speaker programs.
- Review US and, where applicable, global product and disease-state materials and communications for alignment with company goals and applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders.
- Establish working relationships and manage communications with regulatory advertising and promotion professionals at co-promote partner companies.
- Help lead interactions with FDA OPDP for assigned products and maintain effective communication with reviewers, including on advisory submission requests.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements for product and disease-state communications and advise product teams.
- Monitor FDA promotional enforcement activity, regularly update stakeholders, and advise on implications for company policies.
- Provide management with input on process improvements for promotional review and portfolio-wide policy standardization.
- Cross-train across products and indications to maintain continuous Regulatory Advertising and Promotion support.
- Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
- Contribute during review cycles to reflect commercialization objectives and messages in documents and reports submitted to health authorities.
- Provide input during labeling development and negotiation on commercialization objectives and messages that affect promotion and advertising.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
