Sr. Manager Regulatory Affairs, Advertising & Promotion (Remote)
Core
Senior Manager leading regulatory advertising and promotion activities for marketed and pipeline biologic products, ensuring compliance with FDA and global regulations while supporting commercial objectives.
Role type
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Regulatory-compliant advertising and promotion materials, product messages, and submission documents for Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs).
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory affairs expertise, Advertising and promotion regulations knowledge, FDA OPDP interaction, Cross-functional collaboration, Strategic regulatory advice, Compliance monitoring, Process improvement
Preferred skills
Biologics experience, Global promotional review, Clinical trial recruitment materials, Labeling regulations, Conference exhibit management
Technologies
Form 2253, BLA, MAA
Responsibilities
Manage US and Global regulatory activities for advertising and promotion; Advise on product message development; Provide regulatory guidance to Commercial and Medical Affairs; Review promotional materials for compliance; Interact with FDA OPDP; Monitor external regulatory environment; Establish relationships with co-promote partners; Lead interactions with FDA regarding advisory submissions.
Seniority
Senior Manager, hands-on leadership with minimal guidance