Katalyst Healthcares & Life Sciences
CMC Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences, Swiftwater, Pennsylvania, United States, 18370
Job Title
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval. Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and track...
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval. Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and track...