REGULATORY CMC STRATEGY SR SPECIALIST

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Mission Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Evaluate change requests for any of Grifols production sites for regulatory reporting requirements. What your responsibilities will be Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls (CMC) regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Evaluate change requests for any of Grifols production sites for regulatory reporting requirements. Keep track of change requests in the appropriate database.…

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