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The FDA Group

Senior NDA Regulatory Strategist — Remote, Part-Time

boston, MA

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Job description

The FDA Group seeks an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of NDA preparation for a life sciences organization. This remote, part-time role focuses on ensuring the submission is complete, consistent, and positioned for FDA readiness.

The consultant will align with the regulatory project manager, writers and internal stakeholders, review content for gaps and compliance risks, and offer practical guidance.

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Worksite address

boston, MA, 02298, US

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