Global Regulatory Affairs Lead: CMC & Strategy

Pace Analytical Services, LLC; United States; Remote; USD 170,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K retirement plan

Life and disability insurance

Paid time off

Tuition reimbursement

Employee Assistance program

Job summary

Pace Analytical Services, LLC is seeking a seasoned regulatory affairs professional to lead CMC regulatory strategies for investigational and marketed products. The role involves authoring CMC sections, drafting regulatory documents, and guiding interactions with global health authorities to ensure compliance and optimal outcomes.

Ideal candidates have a strong background in biochemistry/chemistry with 10+ years in CMC/regulatory affairs, and experience with FDA/EMA/ICH guidelines and regulatory

Qualifications

• Bachelor's or higher in biochemistry, chemistry, biology, or related field.
• Minimum 10+ years in CMC/regulatory affairs.

Responsibilities

• Author and compile CMC sections for regulatory filings (INDs, IMPDs, CTAs, amendments).
• Draft and maintain CMC regulatory documents (Module 2/3 summaries, stability reports).
• Prepare responses to CMC questions from FDA/EMA/PMDA and others.
• Lead regulatory interactions for CMC strategies to support trials.

Skills

Regulatory submissions

CMC regulatory

Global regulatory strategy

Regulatory writing

Communication

Regulatory operations

Education

Biochemistry/Chemistry/Biology degree

Minimum 10+ years CMC/regulatory affairs

Tools

Regulatory document management systems

Job description

Pace Analytical Services, LLC is seeking a seasoned regulatory affairs professional to lead CMC regulatory strategies for investigational and marketed products. The role involves authoring CMC sections, drafting regulatory documents, and guiding interactions with global health authorities to ensure compliance and optimal outcomes.

Ideal candidates have a strong background in biochemistry/chemistry with 10+ years in CMC/regulatory affairs, and experience with FDA/EMA/ICH guidelines and regulatory