Associate Director, CMC Regulatory Affairs – Small Molecules

Monte Rosa Therapeutics, Inc; Riehen; Vor Ort; CHF 180.000 - 260.000; Vollzeit

Zusammenfassung

Monte Rosa Therapeutics, Inc is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for Chemistry, Manufacturing, and Controls across development stages. You will author Module 3 content, review summaries, and partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to ensure compliant filings.

The ideal candidate has 8+ years in CMC regulatory affairs, experience with IND/CTA submissions and NDA/MAA/BLA,

Qualifikationen

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
• Minimum 8 years in CMC Regulatory Affairs, including direct authorship of Module 3 content.
• Experience preparing IND/CTA submissions; involvement in NDA/MAA/BLA CMC submissions.
• Strong working knowledge of ICH guidelines, FDA/EMA CMC requirements, and cGMP.

Aufgaben

• Develop and execute global CMC regulatory strategies for small molecules across development stages.
• Author, review, and finalize high-quality CMC submission content including CTD Module 3 and QoS summaries.
• Serve as primary CMC regulatory point of contact coordinating input from cross-functional teams.
• Lead CMC regulatory risk assessments and propose mitigation plans.
• Support health authority interactions including pre-IND meetings and response to inquiries.
• Monitor evolving global CMC regulatory guidance and advise stakeholders.

Kenntnisse

CMC Regulatory Affairs

Regulatory writing

IND/CTA submissions

eCTD publishing

Cross-functional collaboration

Project management

CDMOs/CMOs coordination

ICH guidelines knowledge

Ausbildung

Bachelor's in Chemistry/Pharmaceutical Sciences

MS or PhD preferred

Tools

eCTD publishing tools

Regulatory submissions systems

Jobbeschreibung

Monte Rosa Therapeutics, Inc is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for Chemistry, Manufacturing, and Controls across development stages. You will author Module 3 content, review summaries, and partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to ensure compliant filings.

The ideal candidate has 8+ years in CMC regulatory affairs, experience with IND/CTA submissions and NDA/MAA/BLA,