Global Regulatory CMC Lead (Contract)

Pace Analytical Services LLC; Minnesota; Remote; USD 28,103,000 - 56,206,000; Part time

Job summary

Pace Analytical Services LLC is seeking a senior regulatory professional to lead and execute global CMC regulatory strategies for investigational, new, and marketed products. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, while supporting regulatory interactions with global health authorities.

The ideal candidate has extensive hands-on experience, strong writing skills, and a proven ability to manage multiple deliverables in a fast-paced

Qualifications

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

Responsibilities

• Author and compile CMC sections of regulatory applications (INDs, IMPDs, CTAs, amendments, annual reports).
• Draft and maintain CMC documents such as Module 2/3 summaries and stability reports.
• Support regulatory interactions by preparing responses to CMC questions from FDA, EMA, PMDA, and others.
• Lead regulatory interactions for CMC strategies to support clinical trial initiation and advancement.
• Develop templates, processes, and workflows to improve efficiency of CMC regulatory operations.

Skills

Regulatory writing

CMC regulatory

Global submissions

Communication skills

Strategic advisory

Education

Biochemistry/Chemistry/Biology degree

Tools

Regulatory document management systems

Job description

Pace Analytical Services LLC is seeking a senior regulatory professional to lead and execute global CMC regulatory strategies for investigational, new, and marketed products. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, while supporting regulatory interactions with global health authorities.

The ideal candidate has extensive hands-on experience, strong writing skills, and a proven ability to manage multiple deliverables in a fast-paced