Global CMC Regulatory Lead: INDs, CTAs & Submissions

Pace Analytical Services, LLC; North Carolina; Remote; USD 97,000 - 138,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K retirement plan

Life insurance

Disability insurance

Paid time off

HSA

Job summary

Pace Analytical Services, LLC is seeking a senior regulatory affairs professional to lead global CMC regulatory strategies and submissions in the United States. You will author CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, and maintain high-quality regulatory documents.

You will respond to CMC questions from FDA/EMA/PMDA and related authorities, supporting clinical trial initiation and advancement while improving processes and workflows.

Qualifications

• 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, comparability protocols).
• Prepare responses to CMC-related questions from FDA, EMA, PMDA and other authorities.

Responsibilities

• Lead regulatory submissions and strategy for CMC regulatory programs.
• Support interactions with health authorities during regulatory reviews.
• Contribute to development of templates, processes, and workflows for compliant operations.
• Manage multiple deliverables and timelines in a fast-paced environment.”

Skills

Regulatory submissions

CMC regulatory requirements

FDA/EMA/ICH knowledge

Technical writing

Attention to detail

Project management

Regulatory document management

Education

Bachelor's/ Master's/ PhD in biochemistry, chemistry, biology or related pharmaceutical field

Tools

Regulatory document management systems

Job description

Pace Analytical Services, LLC is seeking a senior regulatory affairs professional to lead global CMC regulatory strategies and submissions in the United States. You will author CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports, and maintain high-quality regulatory documents.

You will respond to CMC questions from FDA/EMA/PMDA and related authorities, supporting clinical trial initiation and advancement while improving processes and workflows.