Associate Manager, Regulatory Advertising & Promotion (Remote)
Regeneron Pharmaceuticals
Summary
The Associate Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Associate 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 needed state of compliance and corporate integrity.
Job description
Responsibilities
- Contribute to the management of US regulatory activities associated with advertising and promotion of the company’s marketed products.
- Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Contribute to the advisement on the development of product messages and materials across multiple functional areas.
- Assist with providing timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
- Assist with providing review of US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance.
- Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
- Contributes to the working relationship and handling of communication with regulatory advertising and promotion professionals at co-promote partner companies.
- Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, 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; help assess the potential impact of enforcement activities on the company policies.
- Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies.
- Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
- Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.
Requirements
- A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion or completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion
- Advanced scientific degree (i.e., Masters, PharmD, Ph.D) strongly preferred
- Minimum requirement is a Bachelor's degree (BS) from an accredited college or university in Life Sciences
- Fundamental understanding 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 is highly preferred, biologics experience is a plus
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB is desirable
- Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skill
- Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable
- Ability to influence and guide cross-functional teams
- Ability to interact effectively with senior management and colleagues at all levels
Benefits
- Annual bonuses
- 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
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.