Senior CMC Regulatory Affairs Manager
Core
Lead global CMC regulatory strategy and documentation for biologics programs from pre-clinical through commercialization, ensuring alignment with health authority requirements.
Role type
Senior CMC Regulatory Affairs Manager
Builds
Regulatory submissions (INDs, IMPDs, BLAs, NDAs) and responses to health authority queries for biologics and combination products.
Domain
Biopharmaceuticals / Biologics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, eCTD structure, Module 3 authoring, biologics regulatory knowledge, FDA/EMA/Health Canada regulations, technical writing, change control assessment
Preferred skills
Experience with drug-device delivery systems (pre-filled syringes, auto-injectors), cross-functional project leadership
Technologies
eCTD, Module 3, IMPD, QOS, CTA
Responsibilities
Lead planning and execution of global CMC regulatory submissions; develop responses to health authority queries; provide strategic CMC regulatory guidance and review technical documentation; manage CMC regulatory timelines and deliverables; assess CMC change controls for regulatory impact; partner with Manufacturing, Quality, and Clinical Development teams.
Seniority
Senior, hands-on IC