Remote Associate Manager, Regulatory A&P

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 110,000 - 179,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate Manager in Regulatory Affairs, Advertising and Promotion to apply clinical development knowledge to US messaging and promotional materials for the company’s biologics.

You will coordinate with Marketing, Medical Affairs and Legal; interact with FDA OPDP reviewers; review materials; ensure compliance and timely guidance from leadership.

Qualifications

• Minimum 1–2 years in regulatory affairs, preferably within advertising and promotion.
• Fundamental understanding of pharmaceutical product development and marketing regulations.
• Experience with reviewing promotional materials and interacting with the FDA OPDP/APLB is desirable.

Responsibilities

• Manage US regulatory activities for advertising and promotion with guidance from the APD.
• Advise on development of product messages and materials across functions.
• Review US and Global materials to support corporate goals and comply with regulations.
• Collaborate with Marketing, Medical Affairs and Legal.
• Engage with FDA OPDP reviewers to maintain effective communication.

Skills

Regulatory Affairs

Advertising & Promotion

Cross-functional Collaboration

FDA interactions

Education

Bachelor's degree in Life Sciences

Advanced degree (Masters/PharmD/Ph.D.)

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate Manager in Regulatory Affairs, Advertising and Promotion to apply clinical development knowledge to US messaging and promotional materials for the company’s biologics.

You will coordinate with Marketing, Medical Affairs and Legal; interact with FDA OPDP reviewers; review materials; ensure compliance and timely guidance from leadership.