Senior Regulatory Affairs Lead - Remote, Global Submissions

Pacelabs; United States, Northern America, Americas; Hybrid; USD 99.000 - 135.000; Teilzeit

Benefits dieser Stelle

Medical, dental, vision

401K retirement plan

Life and disability benefits

Paid time off

HSA and wellness program

Tuition reimbursement

Employee Assistance program

Parental leave

ID theft protection

Zusammenfassung

Pace is seeking a Senior Regulatory Affairs Specialist (Remote) to lead global CMC regulatory strategies. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and reports, and draft Module 2/3 documents with precision.

Ideal candidates bring 10+ years in CMC/regulatory affairs, strong documentation skills, and experience interfacing with FDA/EMA/PMDA. Includes a comprehensive benefits program for full-time staff.

Qualifikationen

• BS in biochemistry/chemistry/biology or related field with regulatory experience.
• Experience authoring and compiling CMC sections for INDs/CTAs/IMPDs.
• Strong knowledge of FDA/EMA/ICH guidelines and good writing skills.

Aufgaben

• Author and compile CMC sections of regulatory applications (INDs, IMPDs, CTAs, amendments, annual reports).
• Draft and maintain high‑quality CMC documents (Module 2/3, stability, comparability).
• Prepare responses to CMC questions from FDA, EMA, PMDA, and others.
• Lead regulatory interactions for CMC strategies to support clinical trials.
• Develop templates and workflows to improve CMC regulatory operations.

Kenntnisse

CMC regulatory expertise

Regulatory submissions

Technical writing

Project management

Global regulatory knowledge

Ausbildung

Bachelor's degree in biochemistry/chemistry/biology

MS or PhD in related field preferred

Tools

Regulatory document management systems

Jobbeschreibung

Pace is seeking a Senior Regulatory Affairs Specialist (Remote) to lead global CMC regulatory strategies. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and reports, and draft Module 2/3 documents with precision.

Ideal candidates bring 10+ years in CMC/regulatory affairs, strong documentation skills, and experience interfacing with FDA/EMA/PMDA. Includes a comprehensive benefits program for full-time staff.