Senior Manager, Regulatory Affairs, Advertising & Promotion
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
Deliverable
product features
Required skills
Regulatory affairs expertise, advertising and promotion regulations knowledge, FDA OPDP interaction, cross-functional collaboration, strategic regulatory advice, compliance monitoring, process improvement, global promotional review, clinical trial recruitment material review, labeling regulations familiarity.
Preferred skills
Biologics experience, direct FDA OPDP/APLB interaction experience, global regulatory support experience, understanding of clinical trial recruitment materials.
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 teams; review product and disease state materials; interact with FDA OPDP reviewers; monitor external regulatory environment; support labeling development and negotiation; establish relationships with co-promote partners.
Seniority
Senior Manager, hands-on leadership with minimal guidance