Global Regulatory CMC Lead — Submissions & Strategy

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

Job summary

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.

Qualifications

• Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
• Excellent attention to detail, technical writing, organizational, and communication skills.
• Ability to manage multiple deliverables and timelines in a fast-paced environment.
• Proficiency with regulatory document management systems.

Responsibilities

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

Skills

CMC regulatory experience

Technical writing

Global regulatory

Regulatory strategy

Education

B.A./B.S./M.S./Ph.D. in relevant field

Job description

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.