Global CMC Regulatory Lead – Part-Time (20-40 hrs/mo)

Job description

Pace Analytical Services, LLC is seeking a Senior Regulatory Affairs professional to lead and execute global regulatory strategies for CMC submissions. You will author INDs, IMPDs, CTAs, and amendments, and ensure regulatory documents align with global requirements.

Ideal candidates bring 10+ years in CMC/regulatory affairs with hands-on experience drafting Module 2/3 summaries, stability reports, and responses to health authorities.

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Who can apply

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