Senior CMC Regulatory Lead – Global Submissions

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

Job summary

Pace Analytical Life Sciences seeks a senior regulatory professional to lead global CMC regulatory strategies for investigational and marketed products. You will serve as a strategic advisor to clients, ensuring regulatory compliance and guiding submissions and communications with global health authorities.

The role emphasizes extensive experience in CMC/regulatory affairs, strong technical writing, and the ability to drive multiple deliverables in a fast-paced environment.

Qualifications

• Bachelor's/MS/PhD in biochemistry, chemistry, biology, or related field with 10+ years 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).
• Excellent attention to detail, technical writing, organizational, and communication skills.

Responsibilities

• Author and compile CMC sections of regulatory submissions (INDs, IMPDs, CTAs, amendments, annual reports).
• Draft and maintain CMC regulatory documents (Module 2/3 summaries, stability reports, comparability protocols).
• Support regulatory interactions by preparing responses to CMC-related questions from global authorities.
• Lead regulatory interactions for CMC strategies to support clinical trial initiation and advancement.
• Contribute to development of templates, processes, and workflows for compliant CMC operations.

Skills

Regulatory strategy

CMC/Regulatory affairs

Technical writing

Project management

Education

Biochemistry/ Chemistry/ Biology degree

Tools

Regulatory document management systems

Job description

Pace Analytical Life Sciences seeks a senior regulatory professional to lead global CMC regulatory strategies for investigational and marketed products. You will serve as a strategic advisor to clients, ensuring regulatory compliance and guiding submissions and communications with global health authorities.

The role emphasizes extensive experience in CMC/regulatory affairs, strong technical writing, and the ability to drive multiple deliverables in a fast-paced environment.