Senior Scientist, Regulatory CMC Biologics
Core
Lead regulatory CMC strategies and documentation for biological projects from development through post-approval lifecycle.
Role type
Senior Regulatory CMC Scientist (Biologics)
Builds
Regulatory submissions (IND/IMPD, BLA/MAA) and agency responses for biological drug products
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
CMC documentation, CMC strategy, Regulatory project management, Regulatory compliance, Technical writing, Risk assessment
Preferred skills
Biologics regulatory CMC experience
Technologies
None stated
Responsibilities
Develop robust CMC regulatory strategies, manage execution of CMC documentation for submissions, identify and escalate regulatory issues, ensure compliance with business processes
Seniority
Senior, hands-on IC
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