Global CMC Regulatory Lead — Submissions & Strategy

Pace Analytical Services Llc; Kentucky; Remoto; USD 99.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

401K retirement plan

Descrizione del lavoro

Pace Analytical Services, LLC is seeking a senior regulatory professional for CMC to lead global regulatory submissions and strategies from Kentucky. This role emphasizes authoring CMC sections, preparing summaries and stability reports, and guiding regulatory interactions with major authorities.

The ideal candidate has 10+ years of experience in regulatory affairs, with strong writing, project management, and knowledge of FDA/EMA/ICH guidelines to advance clinical programs and ensure compliant

Competenze

• 10+ years in CMC/regulatory affairs in pharma.
• Experience drafting INDs, IMPDs, CTAs, amendments.
• Knowledge of FDA/EMA/ICH guidelines and global regs.

Mansioni

• Author and compile CMC sections of regulatory submissions.
• Draft Module 2 and 3 summaries, stability reports.
• Respond to CMC questions from FDA/EMA/PMDA and others.
• Lead regulatory interactions for CMC strategies in clinical trials.

Conoscenze

Regulatory strategy

CMC submissions

Technical writing

FDA/EMA/ICH knowledge

Formazione

Biochem/Chem/Biology PhD

Strumenti

Regulatory document management systems

Descrizione del lavoro

Pace Analytical Services, LLC is seeking a senior regulatory professional for CMC to lead global regulatory submissions and strategies from Kentucky. This role emphasizes authoring CMC sections, preparing summaries and stability reports, and guiding regulatory interactions with major authorities.

The ideal candidate has 10+ years of experience in regulatory affairs, with strong writing, project management, and knowledge of FDA/EMA/ICH guidelines to advance clinical programs and ensure compliant