Global CMC Regulatory Strategy Lead

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

Benefits offered by this job

Medical, dental, vision benefits

401K retirement plan with employer-mas

Paid time off

Job summary

Pace Analytical Services, LLC is seeking a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new and marketed products. You will prepare regulatory submissions, author CMC sections, and manage responses to authorities across FDA, EMA and other global bodies.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing skills, and experience with regulatory document management systems in a fast-paced environment.

Qualifications

• Requires a degree in biochemistry, chemistry, biology or related field with 10+ years in CMC/regulatory affairs.
• Hands-on experience authoring and compiling CMC sections for INDs, IMPDs, CTAs and amendments.
• Strong knowledge of FDA, EMA and ICH regulatory guidelines.
• Excellent attention to detail, writing, organization, and communication skills.
• Ability to manage multiple deliverables and timelines in fast-paced environments.
• Experience with regulatory document management systems is preferred.

Responsibilities

• Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Strategy Implementation: Lead regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement.
• Process Development: Contribute to development of templates, processes, and workflows to support efficient CMC regulatory operations.
• Other duties as assigned.

Skills

CMC regulatory

Regulatory submissions

Technical writing

Project management

Education

Biochemistry/Chemistry/Biology degree

Tools

Regulatory document management systems

Job description

Pace Analytical Services, LLC is seeking a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new and marketed products. You will prepare regulatory submissions, author CMC sections, and manage responses to authorities across FDA, EMA and other global bodies.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing skills, and experience with regulatory document management systems in a fast-paced environment.