Associate Director, Global Regulatory CMC
Core
Coordinate global regulatory CMC activities and develop strategies for biologics products through the entire lifecycle, ensuring alignment with business priorities and health authority guidelines.
Role type
Senior IC regulatory affairs manager (biologics CMC)
Builds
Regulatory submissions (IND/CTA/BLA/MAA) and approval pathways for transformative medicines
Domain
Biopharmaceuticals / Biologics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global CMC regulations expertise, CTD format knowledge, manufacturing change control assessment, regulatory application preparation, cross-functional collaboration, independent work
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop/implement CMC regulatory strategies for global submissions, review documents for submission-readiness, lead interactions with health authorities, assess manufacturing change controls, support development of regulatory processes and templates, provide CMC guidance to manufacturing and quality teams, interpret regulatory guidance documents
Seniority
Senior, hands-on IC
