Global CMC Regulatory Lead for Clinical Programs

Pace® Analytical Services; Illinois; Vor Ort; USD 150.000 - 203.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

401(k) plan

Paid time off

Zusammenfassung

Pace® Analytical Services seeks a senior CMC/regulatory professional to lead global regulatory strategies for INDs, IMPDs, CTAs, and post-approval filings. You will author CMC sections, support authorities, and guide submissions in a fast-paced environment.

The ideal candidate has 10+ years in CMC/regulatory affairs, deep FDA/EMA/ICH knowledge, and strong technical writing and program management skills. This is a full-time role in the United States with competitive benefits.

Qualifikationen

• 10+ years of experience in CMC/regulatory affairs.
• Experience authoring CMC sections for INDs/IMPDs/CTAs.
• Knowledge of FDA/EMA/ICH regulations.
• Strong writing, detail, and communication skills.
• Ability to manage multiple deliverables in a fast-paced environment.

Aufgaben

• Author and compile CMC sections for regulatory submissions.
• Draft and maintain CMC documents (Module 2/3, stability reports).
• Prepare responses to FDA/EMA/PMDA inquiries.
• Lead CMC regulatory strategy to support clinical trial initiation and advancement.
• Develop templates and workflows for compliant CMC operations.
• Other duties as assigned.

Kenntnisse

Regulatory strategy

Technical writing

Regulatory submissions

Project management

Ausbildung

BS/MS/PhD in life sciences

Tools

Regulatory document management systems

Jobbeschreibung

Pace® Analytical Services seeks a senior CMC/regulatory professional to lead global regulatory strategies for INDs, IMPDs, CTAs, and post-approval filings. You will author CMC sections, support authorities, and guide submissions in a fast-paced environment.

The ideal candidate has 10+ years in CMC/regulatory affairs, deep FDA/EMA/ICH knowledge, and strong technical writing and program management skills. This is a full-time role in the United States with competitive benefits.