Regulatory Advertising & Promotion Manager

Initial Therapeutics, Inc.; New Jersey; Hybrid; USD 128,600 - 210,000; Full time

Job summary

Regeneron seeks a Manager in Regulatory Affairs Advertising and Promotion to oversee US regulatory activities for drug promotion. You will guide product messages and materials, ensuring compliance with FDA regulations while supporting commercial objectives.

With 2+ years in Regulatory A&P and a life sciences degree (MS/PhD preferred), you will interact with FDA OPDP and cross-functional teams to optimize promotional strategies for marketed products.

Qualifications

• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, focus on advertising and promotion.
• Experience with pharmaceutical products; biologics experience is a plus.
• Experience with FDA interactions (OPDP/APLB) preferred.

Responsibilities

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

Skills

Regulatory A&P

FDA/OPDP liaison

Cross-functional collaboration

Education

Bachelor's in Life Sciences

Advanced degree preferred (MS/PhD/PharmD)

Job description

Regeneron seeks a Manager in Regulatory Affairs Advertising and Promotion to oversee US regulatory activities for drug promotion. You will guide product messages and materials, ensuring compliance with FDA regulations while supporting commercial objectives.

With 2+ years in Regulatory A&P and a life sciences degree (MS/PhD preferred), you will interact with FDA OPDP and cross-functional teams to optimize promotional strategies for marketed products.