Global Regulatory Affairs Lead, CMC Strategy & Submissions

Pace Analytical Services, LLC seeks a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new, and marketed products. You will author and compile CMC sections, draft high-quality regulatory documents, and interact with agencies to support trials and filings.

The ideal candidate brings 10+ years in CMC/regulatory affairs, expertise with FDA/EMA/ICH guidelines, and strong writing and project management skills.