Senior Global Regulatory Affairs Lead – CMC Expert

Pace® Labs; United States; À distance; USD 99 000 - 134 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

401K with employer match

Life insurance

Disability insurance

Paid time off

HSA

Tuition reimbursement

Employee Assistance program

Parental leave

Identity theft protection

Résumé du poste

Pace Labs is seeking an experienced Regulatory Affairs professional to lead CMC submissions and strategies for global regulatory compliance. You will author CMC sections, prepare high-quality regulatory documents, and support interactions with FDA, EMA, and other health authorities.

Ideal candidates hold a higher degree in biochemistry/chemistry/biology with 10+ years in CMC/regulatory affairs and excel in writing, attention to detail, and project coordination in a fast-paced environment.

Qualifications

• Minimum 10+ years in CMC/regulatory affairs.
• Authoring and compiling CMC sections for INDs, IMPDs, CTAs, amendments, and filings.
• Strong knowledge of FDA/EMA/ICH global regulatory requirements.

Responsabilités

• Author and compile CMC sections for regulatory submissions (INDs, IMPDs, CTAs, amendments, annual reports).
• Draft and maintain CMC documents, summaries, stability reports, and comparability protocols.
• Prepare responses to CMC-related questions from global health authorities.
• Lead regulatory interactions and strategies to support clinical trials.

Connaissances

CMC regulatory filings

Regulatory strategy

Technical writing

Project management

Regulatory documents systems

Formation

Bachelor/Master/PhD in Biochemistry/Chemistry/Biology

Outils

Regulatory document management systems

Description du poste

Pace Labs is seeking an experienced Regulatory Affairs professional to lead CMC submissions and strategies for global regulatory compliance. You will author CMC sections, prepare high-quality regulatory documents, and support interactions with FDA, EMA, and other health authorities.

Ideal candidates hold a higher degree in biochemistry/chemistry/biology with 10+ years in CMC/regulatory affairs and excel in writing, attention to detail, and project coordination in a fast-paced environment.