Senior Manager, Regulatory Affairs - Ad & Promo (Remote)

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 151,000 - 246,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) company match

Health benefits

Wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager to lead regulatory affairs for advertising and promotion, translating clinical development into compliant product messages for BLAs/MAAs.

This role supports cross-functional teams across Marketing, Medical Affairs and Legal while maintaining corporate integrity. You will interact with the FDA Office of Prescription Drug Promotion (OPDP), oversee promotional materials, and ensure adherence to applicable laws and guidance for US and global

Qualifications

• Minimum 3–4 years in regulatory affairs, preferably in advertising and promotion.
• Bachelor’s degree in Life Sciences from an accredited college or university.
• Advanced degree (Masters, PharmD, Ph.D., MD/DO) preferred; regulatory experience may offset education.
• Strong knowledge of regulations, guidelines and precedents for pharma product development and marketing, focusing on advertising and promotion.

Responsibilities

• Manage US and Global regulatory activities for advertising and promotion of marketed products and pipeline development.
• Lead regulatory review of product messages and materials with minimal guidance.
• Advise on development of product messages across marketing, medical affairs and legal.
• Interact with FDA OPDP/APLB and coordinate advisory submissions as needed.
• Collaborate with cross-functional teams to ensure compliance and alignment with commercialization objectives.

Skills

Regulatory affairs

Advertising and promotion regulations

Cross-functional collaboration

FDA experience

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred (Masters, Pharm D, Ph.D., MD or DO)

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager to lead regulatory affairs for advertising and promotion, translating clinical development into compliant product messages for BLAs/MAAs.

This role supports cross-functional teams across Marketing, Medical Affairs and Legal while maintaining corporate integrity. You will interact with the FDA Office of Prescription Drug Promotion (OPDP), oversee promotional materials, and ensure adherence to applicable laws and guidance for US and global