Global Regulatory CMC Strategy Lead

Job description

Nuvation Bio, Inc. seeks a Director of Regulatory CMC to steer global strategies for clinical and commercial programs. You will coordinate cross-functional teams to prepare and submit CMC sections for INDs, NDAs/MAAs, and post-approval changes, ensuring compliance with ICH, FDA, EMA, and other authorities.

Ideal candidates bring 10+ years in Regulatory CMC with a proven track record of delivering high-quality global submissions and leading complex programs in a fast-paced biopharma setting.

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Who can apply

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