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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
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University of Texas Medical Branch at Galveston
Galveston, Texas
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Ann & Robert H. Lurie Children's Hospital of Chicago
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Regulatory Affairs CMC Team Lead
The Global Regulatory Affairs CMC Team Lead manages, oversees and develops a team of CMC regulatory professionals and is accountable for all CMC regulatory activities related to product development, registration and license maintenance for the products handled by the team are as follows: For the product portfolio overseen by the team, the GRA CMC Team Lead is also accountable for development and implementation of global CMC regulatory strategies for development and life cycle projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements. Additionally, the position holder might bear operational and strategic CMC regulatory responsibility for products assigned to him/her personally, and in this role will be a
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