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Director / Senior Director, Regulatory Affairs, CMC
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- You will also supervise CMC regulatory staff for multiple product development programs, will assign workload, and oversee CMC staff development and perform management.
- Lead CMC quality execution of all CMC regulatory activities for biologics/gene therapy product development according to business priorities
- In coordination with CMC leadership team, define and implement the global CMC strategy for early health authority interactions through BLA/MAA registration
- Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives
- Work with local agents and experts in Brazil, European Union, Japan and other rest-of-world countries to develop regional CMC regulatory strategies
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