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David Careers

Associate Director, CMC Regulatory Affairs Global Submissions (Remote)

Posted yesterday

ionis pharmaceuticalsDenver (CO)
Regulatory Affairs ManagersPharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds. The role collaborates with cross-functional teams, partners, and vendors to deliver accurate regulatory documentation within timelines and to liaison with authorities for timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain current knowledge of applicable

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