Senior Global CMC Regulatory Lead – IND/CTA Expert

Pace Analytical Services LLC; Illinois; Remote; USD 99,000 - 135,000; Part time

Job summary

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.

Qualifications

• Minimum of 10+ years in CMC/regulatory affairs in pharma.
• Hands-on experience authoring CMC sections for INDs, IMPDs, CTAs, amendments and related filings.
• Strong knowledge of FDA/EMA/ICH guidelines and global regulatory requirements.
• Excellent technical writing and organizational skills.

Responsibilities

• Lead and execute global regulatory strategies for CMC submissions.
• Author and compile CMC sections for regulatory applications and submissions.
• Draft stability reports and comparability protocols.
• Support regulatory interactions by preparing responses from major health authorities.

Skills

Regulatory submissions

Technical writing

Attention to detail

Communication skills

Project management

Education

Biochemistry / Chemistry / Biology degree

Tools

Regulatory document management systems

Job description

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.