Senior Global CMC Regulatory Lead

Pace Analytical Services, LLC; Frederick (MD); Remote; USD 97,000 - 138,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Life insurance

Disability insurance

Paid time off

HSA

Wellness program

Tuition reimbursement

Parental leave

ID theft protection

Job summary

Pace Analytical Services, LLC is seeking a senior CMC/regulatory affairs professional to lead and execute global regulatory strategies for INDs, IMPDs, CTAs, and filings. The role emphasizes high-quality submissions, documentation, and effective communication with FDA, EMA, PMDA, and other authorities.

Strong writing, project management, and regulatory systems experience are required. The ideal candidate has a PhD/MS in a pharmaceutical field with 10+ years of CMC/regulatory affairs experience

Qualifications

• Minimum 10+ years in CMC/regulatory affairs.
• Strong knowledge of FDA, EMA, ICH guidelines.
• Excellent technical writing, attention to detail, and communication skills.

Responsibilities

• Regulatory Submissions: Author and compile CMC sections of INDs, IMPDs, CTAs, amendments, and annual reports.
• Documentation: Draft and maintain CMC regulatory documents (Module 2/3, stability reports, comparability protocols).
• Communication: Prepare responses to CMC questions from FDA, EMA, PMDA and other authorities.
• Strategy Implementation: Lead regulatory interactions to support clinical trial initiation and progression.
• Process Development: Develop templates, processes, and workflows for compliant CMC operations.

Education

BA/MS/PhD in biochemistry/chemistry/biology or related pharmaceutical field

Tools

Regulatory DMS

Job description

Pace Analytical Services, LLC is seeking a senior CMC/regulatory affairs professional to lead and execute global regulatory strategies for INDs, IMPDs, CTAs, and filings. The role emphasizes high-quality submissions, documentation, and effective communication with FDA, EMA, PMDA, and other authorities.

Strong writing, project management, and regulatory systems experience are required. The ideal candidate has a PhD/MS in a pharmaceutical field with 10+ years of CMC/regulatory affairs experience