Global CMC Regulatory Lead — Drug Development

Posted yesterday

pace analytical servicesSaint Paul (MN)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Lead

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About the role

Pace Analytical Services, LLC is seeking an experienced CMC/regulatory affairs professional in Minnesota to lead regulatory submissions and related documentation for investigational, new, and marketed products. The role emphasizes strategic interactions with global authorities and the development of compliant CMC programs. The ideal candidate has 10+ years in CMC/regulatory affairs, hands-on experience with IND/IMPD/CTA filings, and strong writing and communication skills to navigate FDA, EMA,

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