Senior Director, CMC Regulatory Strategy

Posted yesterday

kardiganSouth San Francisco (CA)

Regulatory Affairs Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

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About the role

Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The ideal candidate has 10+ years in CMC regulatory affairs, strong FDA/EMA knowledge, and a track record of global submissions and cross-functional leadership.

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