Regulatory Advertising & Promotion Manager — Hybrid

Regeneron Pharmaceuticals; Warren (MI); Hybrid; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Manager to join the Regulatory Affairs Advertising and Promotion team. You will apply clinical development knowledge and advertising regulations to develop product messages for BLAs/MAAs, guiding stakeholders to ensure compliant communications.

You will oversee US regulatory activities for advertising and promotion, collaborate with cross-functional teams, and liaise with FDA OPDP reviewers to maintain compliant submissions and messaging.

Qualifications

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion.
• Bachelor’s degree in Life Sciences; an advanced degree is preferred.
• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, focusing on advertising and promotion.
• Experience with pharmaceutical products; biologics experience is a plus.
• Experience with FDA OPDP/APLB is preferred.

Responsibilities

• Manage US regulatory activities for advertising and promotion of marketed products.
• Advise on development of product messages and materials across functional areas.
• Provide regulatory guidance to Commercial and Medical Affairs on conferences, disease awareness and speaker programs.
• Review US and Global product and disease state statements to support corporate goals and comply with laws and guidance.
• Collaborate with Marketing, Medical Affairs, and Legal across functions.

Skills

Regulatory affairs

Advertising & Promotion

FDA OPDP

Education

Bachelor’s degree in Life Sciences

Advanced scientific degree preferred

Job description

Regeneron Pharmaceuticals seeks a Manager to join the Regulatory Affairs Advertising and Promotion team. You will apply clinical development knowledge and advertising regulations to develop product messages for BLAs/MAAs, guiding stakeholders to ensure compliant communications.

You will oversee US regulatory activities for advertising and promotion, collaborate with cross-functional teams, and liaise with FDA OPDP reviewers to maintain compliant submissions and messaging.