Senior Global CMC Regulatory Lead – IND/CTA Expert

Pace Analytical Services LLC in Illinois is seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for CMC submissions, including INDs, IMPDs, CTAs, amendments, and annual reports. The role emphasizes high‑quality technical writing and regulatory documentation. The ideal candidate has a minimum of 10+ years in CMC/regulatory affairs, a degree in biochemistry/chemistry/biology, and proven experience drafting modules and responses to FDA/EMA/PMDA.