Manager, Regulatory Affairs, Advertising & Promotion
Core
Manage US regulatory activities for advertising and promotion of marketed biologic products, ensuring compliance with FDA regulations 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 / Biologics / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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 knowledge, labeling regulations familiarity
Technologies
Form 2253, BLAs, MAAs
Responsibilities
Manage US regulatory activities for product advertising and promotion; Provide regulatory advice to Commercial and Medical Affairs teams; Review product and disease state materials for compliance; Interact with FDA OPDP regarding promotional matters; Monitor external regulatory environment for evolving requirements; Collaborate with co-promote partners and cross-functional teams; Support labeling development and marketing application summaries
Seniority
Manager, hands-on IC with strategic guidance