The purpose of the CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate, leads the operational and technical aspects of clinical trial and global marketing authorization submissions for the small and large molecule portfolios in partnership with the Global Regulatory Affairs CMC Regulatory Scientists. The Regulatory Associate partners with the CMC Scientists to create and manage submission documents and provides guidance on structure and content placement. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The Regulatory Associate utilizes submission process expertise to facilitate project management expectations across projects. The scope of work includes global regulatory requirement assessment and understanding strategy development in relation to submission management.
1.Regulatory & Drug Development Expertise