Senior Global CMC Regulatory Lead

Pace Analytical Life Sciences; North Carolina; Remote; USD 97,000 - 138,000; Part time

Benefits offered by this job

Competitive benefits

401(k) retirement plan

Paid time off

Job summary

Pace Analytical Life Sciences is seeking a senior regulatory professional to lead and execute CMC regulatory strategies across global submissions. You will serve as a strategic advisor to clients to ensure compliance with FDA, EMA, and ICH guidelines and help optimize business outcomes.

The role emphasizes authoring CMC sections for INDs, IMPDs, CTAs, amendments, and reports, as well as drafting high-quality regulatory documents and supporting interactions with health authorities.

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

• Lead and execute global regulatory strategies for investigational, new, and marketed products.
• Author and compile CMC sections of regulatory submissions (INDs, IMPDs, CTAs, amendments, annual reports).
• Prepare responses to questions from FDA, EMA, PMDA, and other authorities.
• Lead regulatory interactions for CMC strategies to support clinical trials.
• Develop templates, processes, and workflows for compliant CMC operations.
• Other duties as assigned.

Skills

CMC regulatory writing

Regulatory submissions

Global regulatory requirements

FDA/EMA/ICH knowledge

Regulatory document management systems

Education

Biochemistry / Chemistry / Biology (advanced degree)

Tools

Regulatory document management systems

Job description

Pace Analytical Life Sciences is seeking a senior regulatory professional to lead and execute CMC regulatory strategies across global submissions. You will serve as a strategic advisor to clients to ensure compliance with FDA, EMA, and ICH guidelines and help optimize business outcomes.

The role emphasizes authoring CMC sections for INDs, IMPDs, CTAs, amendments, and reports, as well as drafting high-quality regulatory documents and supporting interactions with health authorities.