Associate Director, Global Regulatory CMC
Core
Coordinate global regulatory CMC activities and develop strategies for biologics products through all lifecycle stages.
Role type
Senior IC regulatory affairs manager (CMC)
Builds
Regulatory submissions (IND/CTA/BLA/MAA) and agency correspondence for transformative medicines
Domain
Biopharmaceuticals / Biologics / Regulatory Affairs
Required skills
Global CMC regulations, CTD format, manufacturing change controls, regulatory procedures, cross-functional collaboration, independent work
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop/implement CMC regulatory strategies for global submissions; Provide guidance for regulatory CMC aspects of product development; Review documents for submission-readiness; Lead Regulatory CMC discussions with health authorities; Perform assessment of manufacturing change controls; Support development of regulatory processes and procedures; Provide CMC regulatory guidance to manufacturing and quality teams
Seniority
Senior, hands-on IC