Global Regulatory Affairs Lead, CMC Strategy & Submissions

Pace Analytical Services, LLC; Minneapolis (MN); Remote; USD 97,000 - 138,000; Full time

Benefits offered by this job

Medical benefits

401K retirement plan

Paid time off

Job summary

Pace Analytical Services, LLC seeks a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new, and marketed products. You will author and compile CMC sections, draft high-quality regulatory documents, and interact with agencies to support trials and filings.

The ideal candidate brings 10+ years in CMC/regulatory affairs, expertise with FDA/EMA/ICH guidelines, and strong writing and project management skills.

Qualifications

• Experience with global regulatory requirements (FDA, EMA, ICH)
• Strong technical writing and attention to detail
• Ability to manage multiple deliverables and timelines

Responsibilities

• Author and compile CMC sections of regulatory applications (INDs, IMPDs, CTAs, amendments, annual reports)
• Draft and maintain CMC regulatory documents (Module 2/3 summaries, stability reports)
• Prepare responses to CMC-related questions from global health authorities (FDA, EMA, PMDA)
• Lead regulatory interactions for CMC strategies to support clinical trials
• Contribute to templates, processes, and workflows for compliant CMC operations
• Perform other duties as assigned

Skills

CMC knowledge

Regulatory writing

Project management

Education

Bachelor's degree in biochemistry/related field

MS or PhD preferred

Tools

Regulatory databases

Job description

Pace Analytical Services, LLC seeks a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new, and marketed products. You will author and compile CMC sections, draft high-quality regulatory documents, and interact with agencies to support trials and filings.

The ideal candidate brings 10+ years in CMC/regulatory affairs, expertise with FDA/EMA/ICH guidelines, and strong writing and project management skills.