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... in the clinical development and regulatory plans. Provide strategic medical input ... adhoc safety monitoring reports to regulatory agencies. May review, assess and ... scientific reports submitted to the..
Job Details: Summary: The Regulatory Analyst position requires knowledge of ... Management (GSM) system. Communicate with regulatory agencies (USDA/FSIS, USDA/AMS, FDA, AAFCO) ... AAFCO) regarding pre-submission strategies, potential regulatory pathways,..
... Investigator's Brochure and local product labeling. This also includes responsibility for ... success, such as delays in regulatory authority approvals and imposition of ... approvals and imposition of restrictive..