Manager, Regulatory Affairs, Advertising & Promotion
Core
Manage US regulatory activities for advertising and promotion of marketed pharmaceutical products, ensuring compliance with FDA regulations and supporting commercial objectives.
Role type
Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Regulatory-compliant advertising and promotion materials for marketed biologics and pharmaceutical products
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Knowledge of FDA advertising and promotion regulations, experience reviewing promotional materials, ability to interact with FDA OPDP, cross-functional collaboration, process improvement
Preferred skills
Biologics experience, global promotional review experience, clinical trial recruitment materials knowledge, labeling regulations familiarity
Technologies
Form 2253, BLA, MAA
Responsibilities
Manage US regulatory activities for advertising and promotion, provide regulatory advice to Commercial and Medical Affairs teams, review product and disease state materials, interact with FDA OPDP reviewers, monitor external regulatory environment, establish relationships with co-promote partners, support launch products and campaigns
Seniority
Manager, hands-on IC