Manager Regulatory Affairs, Advertising & Promotion (Remote)
Core
Manage US regulatory activities for advertising and promotion of marketed biologic products, ensuring compliance with FDA OPDP guidelines and translating clinical development knowledge into compliant product messages.
Role type
Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Compliant advertising and promotion initiatives for biologic products
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory advertising and promotion expertise, FDA OPDP interaction, promotional material review, cross-functional collaboration, process improvement, therapeutic area management
Preferred skills
Biologics experience, global promotional review, clinical trial recruitment materials, labeling regulations
Technologies
Form 2253, BLA, MAA
Responsibilities
Manage US regulatory activities for advertising and promotion; advise on development of product messages and materials; provide regulatory guidance to Commercial and Medical Affairs on conference and speaker programs; review product and disease state materials for compliance; 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