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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
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Ann & Robert H. Lurie Children's Hospital of Chicago
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MANAGER, REGULATORY AFFAIRS
Mission is seeking an experienced and motivated individual to join our Regulatory Affairs team. The Manager - Regulatory Affairs position is responsible for the management and execution of the regulatory compliance activities of Mission and ensures that all applicable regulations and guidelines are followed (US and global). ESSENTIAL DUTIES AND RESPONSIBILITIES: Provides strategic and regulatory guidance relating to Manufacturing and Controls (“CMC”) in the development of strategies across all product life cycles and classifications. Performs regulatory assessments of change controls, deviations and investigations regarding good manufacturing processes (“GMP”). Manages multiple concurrent pr
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