Regulatory Advertising & Promotion Manager

BioSpace; New Jersey; On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Sleepy Hollow, NY or Warren, NJ, seeks a Manager to join Regulatory Affairs Advertising & Promotion.

You will apply clinical development knowledge to develop product messages in BLAs/MAAs and provide regulatory advice to Commercial, Medical Affairs and Legal teams. The role involves coordinating US advertising/regulation reviews, interacting with FDA OPDP, and ensuring compliant promotional materials.

Qualifications

• Knowledge of pharmaceutical advertising regulations and guidelines.
• Experience with regulatory submissions and promo material reviews.
• Ability to interact with FDA OPDP/APLB and cross-functional teams.

Responsibilities

• Manage US regulatory activities for advertising and promotion.
• Advise on development of product messages across functional areas.
• Provide regulatory guidance to Commercial and Medical Affairs for conferences and speaker programs.
• Review US and Global materials for compliance with laws and guidance.

Skills

Regulatory advertising & promotion

FDA OPDP liaison

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in Life Sciences

Advanced scientific degree preferred

Job description

Regeneron Pharmaceuticals, Inc. in Sleepy Hollow, NY or Warren, NJ, seeks a Manager to join Regulatory Affairs Advertising & Promotion.

You will apply clinical development knowledge to develop product messages in BLAs/MAAs and provide regulatory advice to Commercial, Medical Affairs and Legal teams. The role involves coordinating US advertising/regulation reviews, interacting with FDA OPDP, and ensuring compliant promotional materials.