Remote Regulatory Affairs Manager, Advertising & Promotion

Regeneron Pharmaceuticals, Inc.; Oregon; Hybrid; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager to join the Regulatory Affairs Advertising and Promotion team. The role involves applying clinical development knowledge to advertising and promotion regulations as we translate messages for BLAs and MAAs.

The position emphasizes collaboration with Marketing, Medical Affairs and Legal, with responsibilities guiding promotional activities from regulatory perspective and ensuring compliance with FDA expectations.

Qualifications

• Bachelor's degree in Life Sciences required; advanced degree preferred.
• 2+ years of experience in regulatory advertising and promotion or related field.
• Knowledge of regulations, guidelines and precedents for pharmaceutical product marketing.

Responsibilities

• Manage US regulatory activities for advertising and promotion of the company’s marketed products.
• Advise on development of product messages and materials across functions.
• Provide regulatory guidance to Commercial & Medical Affairs on conferences, disease awareness and speaker programs.
• Review US and Global materials for regulatory compliance with guidance from Director.
• Collaborate with Marketing, Medical Affairs and Legal.
• Interact with FDA OPDP/APLB and assist in submissions (Form 2253) where applicable.
• Monitor evolving regulatory requirements affecting product communications and promotions.
• Support portfolio-wide standardization of promotional review processes.

Skills

Regulatory advertising

FDA liaison

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree Life Sciences

Advanced scientific degree

Job description

Regeneron Pharmaceuticals is seeking a Manager to join the Regulatory Affairs Advertising and Promotion team. The role involves applying clinical development knowledge to advertising and promotion regulations as we translate messages for BLAs and MAAs.

The position emphasizes collaboration with Marketing, Medical Affairs and Legal, with responsibilities guiding promotional activities from regulatory perspective and ensuring compliance with FDA expectations.