Associate Director, Regulatory Advertising & Promotion Job at Regeneron in Villa

Associate Director, Regulatory Advertising & Promotion

Regeneron's Regulatory Affairs Organization is seeking an Associate Director to join our Advertising & Promotion team. In This Role, a Typical Day Might Include this 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 independently. The Associate Director Regulatory Affairs, Advertising and Promotion will 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.

This Role Might Be For You If You Can manage US and Global regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. You should be able to:

• Manage commercial activities from a regulatory advertising and promotion perspective independently.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Independently provide regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Independently provide 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.
• Establish working relationship and manage 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.
• Maintain vigilance with respect to FDA promotional enforcement activities and provide stakeholders with updates on a regular basis.
• Cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.

To be considered for this opportunity, you must have the following qualifications:

• At minimum, a Bachelor’s degree (BS) from an accredited College or University in Life Sciences. Advanced degree preferred.
• A minimum of 5 to 7 years within regulatory affairs, preferably within advertising and promotion.
• Expert 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.
• 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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.