Senior Global CMC Regulatory Lead for Pharma Submissions

Pace® Analytical Services; Maryland; On-site; USD 28,103,000 - 56,206,000; Full time

Job summary

Pace® Analytical Services in Maryland seeks an experienced CMC/regulatory affairs professional to lead regulatory submissions and strategies for client programs.

You will author CMC sections, prepare Module 2/3 summaries, and interact with FDA, EMA, PMDA to keep products in compliance. A degree in biochemistry/related field with 10+ years of experience is preferred.

This role offers a competitive hourly rate and a dynamic, mission-driven team environment.

Qualifications

• Minimum 10+ years of experience in CMC/regulatory affairs.
• Hands-on authoring and compiling CMC sections for 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.
• Ability to manage multiple deliverables and timelines in a fast-paced environment.
• Proficiency with regulatory document management systems.

Responsibilities

• Author and compile CMC sections of regulatory submissions, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other authorities.
• Prepare and lead regulatory interactions for CMC regulatory 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

CMC regulatory writing

Regulatory knowledge (FDA/EMA/ICH)

Attention to detail

Time management

Regulatory document management systems

Education

Biochemistry/ Chemistry/ Biology degree

Job description

Pace® Analytical Services in Maryland seeks an experienced CMC/regulatory affairs professional to lead regulatory submissions and strategies for client programs.

You will author CMC sections, prepare Module 2/3 summaries, and interact with FDA, EMA, PMDA to keep products in compliance. A degree in biochemistry/related field with 10+ years of experience is preferred.

This role offers a competitive hourly rate and a dynamic, mission-driven team environment.