Global CMC Regulatory Lead: Submissions & Strategy

Posted yesterday

pace analytical servicesSaint Paul (MN)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

Pace® Analytical Services is seeking a senior regulatory affairs professional in Minnesota to lead CMC submissions and global regulatory strategies. The role involves authoring CMC sections, drafting submissions, and coordinating responses with FDA, EMA, and PMDA to ensure compliance across markets. The ideal candidate has 10+ years in CMC/regulatory affairs, with strong technical writing, attention to detail, and proficiency in regulatory document management systems.

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Your notice period

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Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.