Global CMC Regulatory Lead — Senior

Pace Analytical Services LLC; Maryland; Remote; USD 70,000 - 117,000; Full time

Benefits offered by this job

Medical Benefits

Dental & Vision

401K matching (100% vesting)

Life Insurance

Disability benefits

PTO & holidays

HSA

Wellness program

Tuition reimbursement

Employee Assistance Program

Parental Leave

Legal coverage

Job summary

Pace Analytical Services LLC is seeking a senior CMC/regulatory affairs leader to author and coordinate regulatory submissions (INDs, IMPDs, CTAs) and related CMC documents. You will liaise with global health authorities to ensure compliance and expedite clinical trial initiation.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing, and hands-on experience with FDA/EMA guidelines.

Qualifications

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

Responsibilities

• Lead and execute global regulatory strategies for CMC submissions.
• Author and compile CMC sections for regulatory applications.
• Draft high-quality regulatory documents (Module 2/3, stability reports, comparability protocols).
• Support interactions with FDA, EMA, PMDA and other health authorities.
• Develop templates, processes, and workflows to improve CMC regulatory operations.

Skills

CMC regulatory

Regulatory writing

Global regulatory

Education

Biochemistry/Chemistry/Biology degree

MS/PhD in related field

Tools

Regulatory DMS

Job description

Pace Analytical Services LLC is seeking a senior CMC/regulatory affairs leader to author and coordinate regulatory submissions (INDs, IMPDs, CTAs) and related CMC documents. You will liaise with global health authorities to ensure compliance and expedite clinical trial initiation.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing, and hands-on experience with FDA/EMA guidelines.