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Remote CMC Regulatory Lead - Gene Therapy

Astellas Pharma

Astellas in Westborough, MA is seeking a senior Regulatory CMC leader to develop and drive global CMC regulatory strategy and submissions. You will collaborate with RA, QA, and technical teams across regions to ensure compliant, timely registrations for NMEs and changes.

This role requires a BS in Biology or equivalent with 10 years in the pharma industry and at least 6 in Regulatory Affairs or CMC, strong English communication, and experience with EU/US/Japan regulations.

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Vacancy posted 9 hours ago
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