Senior Global CMC Regulatory Lead

Pace Analytical Services, LLC; Massachusetts; Remote; USD 99,000 - 135,000; Full time

Job summary

Pace Analytical Services, LLC is seeking a regulatory affairs professional with extensive CMC experience to lead regulatory submissions for INDs, IMPDs, CTAs, and related filings. The role focuses on authoring modules, ensuring compliance with global guidelines, and supporting FDA/EMA interactions.

The ideal candidate brings strong technical writing, attention to detail, and the ability to manage multiple deliverables in a fast-paced environment while working a Monday–Friday schedule in

Qualifications

• Minimum 10+ years of experience in CMC/regulatory affairs.
• Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Strong knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH).

Responsibilities

• Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Prepare responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Prepare and Lead Regulatory interactions for CMC strategies to support clinical trial initiation and advancement.
• Contribute to development of templates, processes, and workflows to support compliant CMC regulatory operations.
• Other duties as assigned.

Skills

CMC experience

Regulatory strategy

Technical writing

FDA/EMA knowledge

Education

Biochemistry/Chemistry/ Biology degree

Job description

Pace Analytical Services, LLC is seeking a regulatory affairs professional with extensive CMC experience to lead regulatory submissions for INDs, IMPDs, CTAs, and related filings. The role focuses on authoring modules, ensuring compliance with global guidelines, and supporting FDA/EMA interactions.

The ideal candidate brings strong technical writing, attention to detail, and the ability to manage multiple deliverables in a fast-paced environment while working a Monday–Friday schedule in