Associate Director, Regulatory Affairs – CMC 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

Overview

Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This individual will partner closely with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to develop CMC regulatory strategy, author and review high-quality submission content (Module 3 and associated summaries), and represent CMC in interactions with health authorities. The role requires strong technical CMC knowledge, regulatory acumen across ICH guidelines, and the ability to operate independently in a fast-paced, growing clinical-stage environment.

Responsibilities

• Develop and execute global CMC regulatory strategies for small-molecule molecule glue degrader drug substances and drug products across all phases of development (IND/CTA through NDA/MAA).
• Author, review, and finalize high-quality CMC regulatory submission content, including CTD Module 3 (2.3, 3.2.S, 3.2.P), Module 2.3 Quality Overall Summary, IMPD, and responses to health authority information requests.
• Serve as the primary CMC regulatory point of contact for assigned programs, coordinating cross-functional input from Process Chemistry, Analytical Development, Drug Product, Formulation, Quality Assurance, Quality Control, and CDMO/CMO partners.
• Lead CMC regulatory risk assessments, identify potential gaps or issues in manufacturing and control strategies, and propose mitigation plans in collaboration with technical teams.
• Support health authority interactions (FDA, EMA, and other global regulators) related to CMC, including pre-IND meetings, Type B/C meetings, and responses to information requests, deficiency letters, and clinical holds.
• Monitor and interpret evolving global CMC regulatory guidance and requirements and advise internal stakeholders on implications for Monte Rosa's programs.
• Contribute to the development and maintenance of internal CMC regulatory SOPs, templates, and best practices as the company scales toward late-stage development and commercialization.

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree (M.S. or Ph.D.) preferred.
• Minimum 8 years of progressive experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry, including direct authorship of Module 3 content for small-molecule programs.
• Demonstrated experience preparing and/or supporting IND/CTA submissions, and direct involvement in at least one NDA/MAA or BLA CMC submission is highly desirable.
• Strong working knowledge of ICH guidelines, FDA and EMA CMC regulatory requirements, and current Good Manufacturing Practice (cGMP) principles.
• Experience collaborating with CDMOs/CMOs and cross-functional technical development teams (process chemistry, analytical, drug product) in an outsourced manufacturing model.
• Excellent scientific writing, document review, and communication skills, with the ability to translate complex technical data into clear regulatory narrative.
• Strong project management skills with the ability to manage multiple submissions and competing timelines in a fast-paced, resource-conscious environment.
• Experience with electronic submission publishing tools and eCTD structure and lifecycle management