Remote Director, Regulatory CMC - Global Submissions Leader

Posted yesterday

immuneeringSomerville (MA)

Regulatory Affairs Managers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

Immuneering Corporation in Cambridge, MA seeks a Director of Regulatory CMC to lead global CMC regulatory strategies for investigational and commercial products. You will prepare and submit CMC sections for INDs, NDAs, and other filings, interfacing with FDA/EMA and cross-functional teams. The ideal candidate has 10+ years in CMC regulatory affairs, deep FDA/EMA knowledge, and strong leadership and project-management skills.

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Your notice period

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