Associate Manager, Regulatory Advertising & Promotion
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 Advertising & Promotion
Builds
Regulatory-compliant advertising and promotion initiatives for marketed biologic products
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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 submissions, Cross-functional collaboration, Regulatory strategy alignment
Preferred skills
Post-Doctoral Fellowship experience, Biologics experience, Global promotional review, Clinical trial recruitment materials, Labeling regulations, Conference exhibit management, Disease awareness programs
Technologies
Form 2253, FDA OPDP systems
Responsibilities
Manage US regulatory activities for advertising and promotion of marketed products, Advise on development of product messages and materials, Provide regulatory guidance to Commercial and Medical Affairs teams, Review US and Global product/disease state communications, Interact with FDA OPDP reviewers regarding advertising matters, Monitor external environment for evolving regulatory requirements, Assess impact of FDA enforcement activities on company policies
Seniority
Associate Manager, hands-on IC with mentorship potential