Associate Director of Regulatory Affairs, CMC
Core
Lead CMC regulatory submissions and lifecycle management for late-stage cell therapy products, ensuring compliance with global health authorities.
Role type
Senior individual contributor regulatory affairs director (CMC)
Builds
BLA, MAA, IND, IMPD submissions and Module 3/CTD documentation for cell therapy pipelines
Domain
Biopharmaceuticals / Cell and Gene Therapy
Required skills
CMC regulatory strategy, Module 3/CTD authoring, global submission management (FDA, EMA, ANVISA), health authority interaction, lifecycle management, scientific writing, process characterization, analytical method validation, stability study design, technology transfer
Preferred skills
Allogeneic/autologous cell therapy platform experience, late-stage/commercial BLA/MAA submission history, Health Canada/PMDA familiarity
Technologies
CTD, ICH Q5–Q12 guidelines
Responsibilities
Author and review CMC sections for late-stage and commercial regulatory submissions; Support commercial lifecycle management including post-approval supplements and manufacturing changes; Prepare and coordinate health authority interactions and briefing documents; Partner with cross-functional teams to provide CMC regulatory guidance; Monitor evolving global CMC regulations and cell/gene therapy guidance; Provide mentorship to junior regulatory professionals
Seniority
Senior, hands-on IC