Global Regulatory CMC Lead — Submissions & Strategy

Pace Analytical Services LLC in Massachusetts seeks a senior regulatory affairs professional to lead global CMC strategies and ensure compliance for investigational and marketed products across INDs, IMPDs, CTAs, and related filings. The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing, and proven experience interfacing with FDA, EMA, and PMDA. This role emphasizes strategy, documentation, and cross-functional collaboration.