Global CMC Regulatory Lead: Submissions & Strategy

Pace® Analytical Services; Minnesota; On-site; USD 110,000 - 124,000; Part time

Benefits offered by this job

Comprehensive benefits package

401K retirement plan

Paid time off

Job summary

Pace® Analytical Services is seeking a senior regulatory affairs professional in Minnesota to lead CMC submissions and global regulatory strategies. The role involves authoring CMC sections, drafting submissions, and coordinating responses with FDA, EMA, and PMDA to ensure compliance across markets.

The ideal candidate has 10+ years in CMC/regulatory affairs, with strong technical writing, attention to detail, and proficiency in regulatory document management systems.

Qualifications

• Minimum 10+ years of experience in CMC/regulatory affairs.
• Authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Strong knowledge of FDA, EMA, and ICH guidelines.
• Excellent attention to detail, technical writing, organizational, and communication skills.

Responsibilities

• Regulatory Submissions: Author and compile CMC sections of regulatory applications.
• Documentation: Draft and maintain high-quality CMC regulatory documents.
• Communication: Support regulatory interactions with health authorities.
• Strategy Implementation: Lead CMC regulatory strategies for clinical trials.
• Process Development: Develop templates, processes, and workflows for compliant CMC operations.
• Other duties as assigned.

Skills

Regulatory writing

Project management

Attention to detail

Technical writing

Communication skills

Education

B.A./M.S./Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field

Tools

Regulatory document management systems

Job description

Pace® Analytical Services is seeking a senior regulatory affairs professional in Minnesota to lead CMC submissions and global regulatory strategies. The role involves authoring CMC sections, drafting submissions, and coordinating responses with FDA, EMA, and PMDA to ensure compliance across markets.

The ideal candidate has 10+ years in CMC/regulatory affairs, with strong technical writing, attention to detail, and proficiency in regulatory document management systems.