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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
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University of Texas Medical Branch at Galveston
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Ann & Robert H. Lurie Children's Hospital of Chicago
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Head of Global Regulatory Affairs
Title: Head of Global Regulatory Affairs About Working with a key pharmaceutical client on a BRAND-NEW Head of Regulatory Affairs position. Reporting to the CEO, The Head of Regulatory Affairs will lead the entire Regulatory function in the development and implementation of regulatory strategies and operations ensuring timely delivery of regulatory submissions. The Head of Regulatory Affairs is responsible to compile, prepare, and review the various documents for content completeness and compliance with all the regulatory requirements. Responsibilities Lead the Regulatory preparations and submissions of documents to support investigations and marketing registrations Submissions include IND/NDA/CTA/eCTD/CTD/ANDA, Amendments, Annual Reports
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