Associate Manager, Regulatory Advertising & Promotion (Remote)

Build our future together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager to join our Regulatory Affairs Advertising and Promotion team.

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Discover your role

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, with guidance from Regulatory Affairs, Advertising & Promotion Director, 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 (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.

Ability to 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, assist with 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; 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

Knowledge of products/indications to help provide continuous Regulatory A&P support is provided to stakeholders