Senior Manager Regulatory Affairs

Job Summary

Seeking a full-time Senior Manager Regulatory Affairs in Advertising & Promotion, this remote position will manage regulatory activities related to the advertising and promotion of marketed products and pipeline developments while advising on product messaging and ensuring compliance with applicable regulations.

Key responsibilities

• Manage US and Global regulatory activities associated with advertising and promotion for marketed and pipeline products
• Advise on the development of product messages and materials across multiple functional areas while ensuring compliance
• Collaborate with cross-functional teams and maintain communication with FDA regarding advertising and promotion matters

Required qualifications

• 3 to 4 years of experience in regulatory affairs, preferably in advertising and promotion
• Bachelor's degree in Life Sciences; advanced degree preferred
• Advanced knowledge of regulations related to pharmaceutical product development and marketing
• Experience with pharmaceutical products; biologics experience is a plus
• Ability to interact with FDA and manage promotional materials and campaigns effectively