Associate Director, CMC Regulatory Affairs
Core
Executes multi-product global regulatory CMC strategies for investigational and marketed products, leading preparation and filing of regulatory CMC submissions and managing interactions with Health Authorities.
Role type
Associate Director, CMC Regulatory Affairs
Builds
Global CMC regulatory strategies and submissions for investigational and commercial products
Domain
Pharmaceutical/Biotech Regulatory Affairs
Required skills
Global CMC regulatory strategy, FDA/EMA/Health Canada/ICH guidelines, change controls, GMP investigations, cross-functional leadership, regulatory submission preparation
Preferred skills
Strategic thinking, problem solving, planning and prioritization
Technologies
Regulatory guidelines (FDA, EMA, Health Canada, ICH)
Responsibilities
Lead preparation and review of CMC sections of regulatory submissions; Develop global CMC regulatory strategies; Provide CMC regulatory guidance to cross-functional teams; Manage regulatory assessment on product compliance topics including change controls and GMP investigations; Act as primary regulatory CMC contact for assigned products
Seniority
Senior, hands-on IC with supervisory responsibilities