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Regulatory Affairs ManagerAllegis Group - Deerfield, ILSummary: Perform the day-to-day activities related to organization and submission of regulatory documents directly to the Federal Drug Administration (FDA). Job Requirements: Compile, edit, and submit regulatory submissions together with their amendments and supplements to FDA and other regulatory agencies. Interaction with Research & Development, Quality Assurance/Quality Control, and Production for gathering data and documentation for submissions. Communicate with FDA and other regulatory agencies to obtain approvals for submissions and supplements. Respond to deficiency letters from FDA on submissions. Coordinate post-approval commitments for submission. Review and generate SOPs for the Regulatory Affairs group. Develop draft labeling for proposed and existing drug products. Review product...originally from Allegis Group - More Tools...
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