Sr Manager, Regulatory Affairs CMC
Core
Lead regulatory strategy for CMC submissions of biologics molecules to ensure global approvals and maintain clinical/commercial submissions.
Role type
Senior Manager, CMC Regulatory Affairs (Biologics)
Builds
Global regulatory submissions (INDs, CTAs, NDAs, MAAs) and amendments for biologics 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, global regulatory landscape knowledge, regulatory document preparation, cross-functional collaboration, team leadership, ICH guidelines interpretation
Preferred skills
Experience with investigational and commercial product submissions
Technologies
Regulatory submission systems, ICH guidelines frameworks
Responsibilities
Prepare and submit complex regulatory documents for investigational and commercial products; develop regulatory strategies for CMC challenges; interpret and implement global CMC guidelines; partner with PDM and other functional groups; lead small teams in strategy execution
Seniority
Senior Manager, hands-on IC with team leadership
