Sr. Manager Regulatory Affairs Advertising & Promotion

The Senior 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). We expect the Sr. Manager to provide regulatory advertising and promotion expertise to relevant collaborators, typically carrying out the responsibilities with minimal guidance from the Director. We predict that the Sr. Manager will supervise therapeutic area(s) and 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.

In this role, a typical day might include the following:

• Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. Handles 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 timely 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 goals of the company and follow applicable laws, regulations, and guidance.
• Collaborate cross functionally with key partners in areas such as Marketing, Medical Affairs, and Legal.
• Responsible for establishing relationship and leading 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, responsible for 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

You bring knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion

You have experience with pharmaceutical products required, biologics experience is a plus

You work directly with authorities, specifically OPDP/APLB is required

You can 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

You handle global promotional review, clinical trial recruitment materials, and familiarity with labeling regulations is preferred

Proven track record to lead and influence cross-functional teams and work effectively with senior management

To be consider, we expect you to have 4 years of Regulatory Ad/Promo experience along with a scientific degree. It is preferred to have a MS, PharmD, PhD but Bachelors is a minimum requirement.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.