Position Summary:
The AD, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases of development, post-approval, and life cycle of the product depending on assigned products. Primary responsibilities will be in creating CMC regulatory strategies for development programs in preparation and maintenance of regulatory applications.
Essential Functions of the Job:
+ Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.<...