Associate Manager, Regulatory Advertising & Promotion (Remote)
Core
Apply clinical development knowledge and advertising/promotion regulations to develop key product messages for Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs) while ensuring compliance.
Role type
Associate Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Regulatory advertising and promotion initiatives for marketed biologic products
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Clinical development knowledge, Advertising and promotion regulations, Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs), FDA OPDP interaction, Promotional material review, Form 2253 compliance, Cross-functional collaboration, Labeling development, Process improvement for promotional review
Preferred skills
Post-Doctoral Fellowship experience, Advanced scientific degree (Masters/PharmD/PhD), Biologics experience, Global promotional review, Clinical trial recruitment materials, Labeling regulations
Technologies
None stated
Responsibilities
Manage US regulatory activities for advertising and promotion, Advise on product message development, Provide regulatory guidance to Commercial and Medical Affairs, Review product and disease state materials, Interact with FDA OPDP reviewers, Monitor external regulatory environment, Assess impact of FDA enforcement activities
Seniority
Associate Manager, hands-on IC