Global CMC Regulatory Lead – Part-Time (20-40 hrs/mo)

Pace Analytical Services, LLC; Attleboro (MA); Remote; USD 117,000 - 138,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401K plan

Job summary

Pace Analytical Services, LLC is seeking a Senior Regulatory Affairs professional to lead and execute global regulatory strategies for CMC submissions. You will author INDs, IMPDs, CTAs, and amendments, and ensure regulatory documents align with global requirements.

Ideal candidates bring 10+ years in CMC/regulatory affairs with hands-on experience drafting Module 2/3 summaries, stability reports, and responses to health authorities.

Qualifications

• PhD/MS/BA in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 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 clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
• Excellent attention to detail, technical writing, organizational, and communication skills.

Responsibilities

• Author and compile CMC sections of regulatory submissions (INDs/IMPDs/CTAs/amendments).
• Draft and maintain high-quality CMC documents such as summaries and stability reports.
• Prepare responses to CMC questions from global health authorities.
• Lead CMC regulatory strategies to support clinical trial initiation and advancement.
• Contribute to templates, processes, and workflows to support compliant CMC operations.

Skills

CMC regulatory

Regulatory submissions

Regulatory strategy

FDA knowledge

Technical writing

Regulatory documents

Education

Biochemistry/Chemistry/Biology degree (BA/MS/PhD)

Tools

Document management systems

Job description

Pace Analytical Services, LLC is seeking a Senior Regulatory Affairs professional to lead and execute global regulatory strategies for CMC submissions. You will author INDs, IMPDs, CTAs, and amendments, and ensure regulatory documents align with global requirements.

Ideal candidates bring 10+ years in CMC/regulatory affairs with hands-on experience drafting Module 2/3 summaries, stability reports, and responses to health authorities.