Senior Regulatory Project Lead - IND to NDA Strategy

Posted yesterday

bayside solutionsCalifornia (MO)

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

SENIORITY

Manager

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About the role

Bayside Solutions is seeking an Associate Director, Regulatory Project Manager Contractor to drive regulatory timelines from IND/CTA through BLA/NDA/MAA, coordinating cross-functional teams and external vendors to maintain on-time, compliant submissions. The role emphasizes risk anticipation, strategic resourcing, and collaboration with Regulatory Affairs, Medical Writing, and project SMEs to advance neurodegenerative therapy programs.

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