Part-Time Global Regulatory Affairs Strategist (CMC)

Pace Analytical Life Sciences; Illinois; Remote; USD 97,000 - 138,000; Full time

Job summary

Pace Analytical Life Sciences is seeking an experienced regulatory professional to lead global CMC strategies and author regulatory submissions for investigational and marketed products. The role acts as a strategic advisor to clients, ensuring compliance with FDA, EMA, PMDA and other authorities.

The ideal candidate will have 10+ years in CMC/regulatory affairs, strong technical writing, and proficiency with regulatory document management systems.

Qualifications

• Five or more years of experience in CMC/regulatory affairs.
• Experience authoring and compiling CMC sections for INDs, IMPDs, CTAs and amendments.
• Knowledge of FDA, EMA, ICH guidelines and global regulatory requirements.

Responsibilities

• Author and compile CMC sections for regulatory submissions.
• Draft and maintain CMC regulatory documents (Module 2/3 summaries, stability reports).
• Support FDA/EMA/PMDA responses to regulatory inquiries.
• Lead regulatory interactions for CMC strategies to support clinical trials.
• Contribute to templates, processes, and workflows for compliant CMC operations.
• Perform additional duties as assigned.

Skills

Regulatory strategy

CMC regulatory knowledge

Technical writing

Regulatory submissions

Project management

Education

Bachelor's/M.S./Ph.D. in biochemistry, chemistry, biology or related field

Tools

Regulatory document management systems

Job description

Pace Analytical Life Sciences is seeking an experienced regulatory professional to lead global CMC strategies and author regulatory submissions for investigational and marketed products. The role acts as a strategic advisor to clients, ensuring compliance with FDA, EMA, PMDA and other authorities.

The ideal candidate will have 10+ years in CMC/regulatory affairs, strong technical writing, and proficiency with regulatory document management systems.