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MSD Malaysia

Regulatory CMC Biologics Lead - Associate Principal

northern, KY

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Job description

Merck & Co., Inc. seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global CMC regulatory strategies. You will prepare and submit CMC sections for biologics, mentor junior staff, and collaborate across functional areas to ensure timely submissions.

You will contribute to IND/BLA filings, post-approval changes, and cross-functional regulatory programs, ensuring scientific rigor and regulatory compliance within a biotech environment.

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