Global CMC Regulatory Strategist, Small Molecules

Monte Rosa Therapeutics, Inc.; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Monte Rosa Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing, and Controls across development stages. You will author and review Module 3, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and interact with health authorities.

The role requires strong technical CMC knowledge, regulatory acumen across ICH guidelines, and the ability to operate

Qualifikationen

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field; advanced degree preferred.
• Minimum 8 years of progressive experience in CMC Regulatory Affairs.
• Direct authorship of Module 3 content for small-molecule programs is required.
• Experience preparing IND/CTA submissions and involvement in NDA/MAA/BLA CMC submissions.
• Strong knowledge of ICH guidelines, FDA/EMA CMC requirements, and cGMP principles.
• Experience collaborating with CDMOs/CMOs and cross-functional technical teams.
• Excellent scientific writing and communication skills; able to translate complex data.

Aufgaben

• Develop and execute global CMC regulatory strategies for small-molecule programs across development.
• Author, review, and finalize CMC submission content including CTD Module 3 and summaries.
• Serve as primary CMC regulatory contact for programs; coordinate input from multiple functions.
• Lead regulatory risk assessments and propose mitigation plans with technical teams.
• Support health authority interactions (FDA, EMA, and others) including meetings and responses.
• Monitor evolving global CMC guidance and advise stakeholders on implications.
• Develop and maintain internal CMC regulatory SOPs, templates, and best practices.

Kenntnisse

ICH guidelines knowledge

Regulatory writing

eCTD publishing

Cross-functional collaboration

Project management

FDA/EMA CMC awareness

Ausbildung

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Tools

CDMO/CMO coordination

Jobbeschreibung

Monte Rosa Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing, and Controls across development stages. You will author and review Module 3, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and interact with health authorities.

The role requires strong technical CMC knowledge, regulatory acumen across ICH guidelines, and the ability to operate