Global CMC Regulatory Lead — Submissions & Strategy

Pace Analytical Services, LLC; Morrisville (NC); Remote; USD 117,000 - 138,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

401K plan

HSA

Job summary

Pace Analytical Services, LLC in Morrisville, NC seeks a senior Regulatory Affairs professional to lead global CMC regulatory strategies and ensure compliance for investigational, new, and marketed products. The role involves authoring and compiling CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, and acting as strategic advisor to clients.

Ideal candidate has 10+ years in CMC/regulatory affairs with advanced degrees, strong writing skills, and experience with FDA/EMA/ICH

Qualifications

• 10+ years of experience in CMC/regulatory affairs.
• Hands-on experience authoring CMC sections for INDs, CTAs, amendments, and related filings.
• Strong knowledge of FDA, EMA, and ICH guidelines.
• Excellent technical writing and communication skills.
• Ability to manage multiple deliverables in a fast-paced environment.

Responsibilities

• Author and compile CMC sections of regulatory submissions.
• Draft and maintain high-quality CMC documents such as summaries, stability reports, and comparability protocols.
• Respond to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Lead regulatory interactions for CMC strategies to support clinical trial initiation and advancement.
• Contribute to development of templates, processes, and workflows to support compliant CMC operations.
• Other duties as assigned.

Skills

Regulatory strategy

CMC submissions

Regulatory writing

FDA/EMA/ICH knowledge

Project management

Education

Bachelor's degree in biochemistry/chemistry/biology or related field

Tools

Regulatory document management systems

Job description

Pace Analytical Services, LLC in Morrisville, NC seeks a senior Regulatory Affairs professional to lead global CMC regulatory strategies and ensure compliance for investigational, new, and marketed products. The role involves authoring and compiling CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, and acting as strategic advisor to clients.

Ideal candidate has 10+ years in CMC/regulatory affairs with advanced degrees, strong writing skills, and experience with FDA/EMA/ICH