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 GRA-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.
This is accomplished by a strong working knowledge of customers, internal procedures, regulatory guidance and precedence. The Regulatory Associate triages and manages communications between mi client’s global Affiliates, GRA-CMC Scientists, CMC teams, Clinical teams, and Quality/Regulatory Representatives. 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.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory & Drug Development Expertise
Lead, Influence, Partner
Minimum Qualification Requirements:
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