Associate Manager, Regulatory Advertising & Promotion (Remote)
About The Position
Regeneron is seeking an Associate Manager to join its Regulatory Affairs Advertising and Promotion team. The role applies clinical development knowledge and understanding of advertising and promotion regulations and guidance to the development of key product messages used in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). With guidance from the Regulatory Affairs, Advertising and Promotion Director, the Associate Manager provides regulatory advertising and promotion expertise to stakeholders and oversees therapeutic area(s). The role helps translate product messages into advertising and promotion initiatives that meet commercial objectives while maintaining compliance and corporate integrity. The position contributes to US regulatory activities for advertising and promotion of marketed products, advises on product messages and materials, and supports Commercial and Medical Affairs teams. It reviews US and, where applicable, global product and disease-state communications; supports interactions with FDA's Office of Prescription Drug Promotion (OPDP); and ensures compliance with promotional material submissions to FDA on Form 2253. The Associate Manager monitors regulatory developments and enforcement activity, contributes to promotional review process improvements, and collaborates with Regulatory Therapeutic Area Leads on marketing application summaries, study reports, labeling, and commercialization objectives. The role is remote in the United States, five days a week.
Requirements
- At least 1 to 2 years of experience in regulatory affairs, preferably in advertising and promotion, or completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion.
- Bachelor's degree (BS) in Life Sciences from an accredited college or university.
- Fundamental understanding of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, particularly advertising and promotion.
- Ability to review promotional materials and interact with FDA OPDP/APLB and help support product launches and campaigns.
- Excellent written and verbal communication skills.
- Ability to influence and guide cross-functional teams.
- Ability to interact effectively with senior management and colleagues at all levels.
Nice To Haves
- Advanced scientific degree, such as a Master's, PharmD, or Ph.D.
- Experience with pharmaceutical products; biologics experience is a plus.
- Experience working directly or indirectly with the FDA, particularly OPDP/APLB.
- Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations.
Responsibilities
- Contribute to management of US regulatory activities associated with advertising and promotion of the company's marketed products.
- Manage commercial activities from a regulatory advertising and promotion perspective, with guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Contribute advice on the development of product messages and materials across multiple functional areas.
- Assist in providing timely regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness, and speaker programs.
- Assist with reviewing US and, if applicable, global product and disease-state materials and communications for corporate goals and compliance with applicable laws, regulations, and guidance.
- Collaborate with stakeholders in Marketing, Medical Affairs, Legal, and other functional areas.
- Contribute to working relationships and communications with regulatory advertising and promotion professionals at co-promote partner companies.
- Assist with interactions with FDA OPDP for assigned company products, including communications with reviewers and advisory submission requests.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor the external environment and advise product teams about evolving regulatory requirements related to product and disease-state communications.
- Monitor FDA promotional enforcement activities, update stakeholders regularly, and help assess implications for company policies.
- Contribute knowledge of process improvement for promotional review activities and portfolio-wide standardization of policies.
- Maintain knowledge of products and indications to provide ongoing Regulatory Advertising and Promotion support to stakeholders.
- Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
- Apply input from review cycles to reflect commercialization objectives and messages in documents and reports submitted to health authorities.
- Work with management during labeling development and negotiation to reflect commercialization objectives and messages affecting 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, insurance benefits, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
