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Regulatory Affairs Manager — FDA Strategy & CMC Lead

Prolacta

Prolacta Bioscience in Duarte, CA seeks a Manager of Regulatory Affairs to guide regulatory strategy and manage submissions for clinical development programs, including INDs and NDA filings, with global regulatory coordination (FDA, PMDA, ICH). This role supports lifecycle activities, CMC, and pharmacovigilance across products. The candidate will lead regulatory strategy, ensure compliance with GxP and FDA regulations, and collaborate with cross-functional teams to drive programs forward in a #J-18808-Ljbffr Prolacta

Vacancy posted 5 days ago
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