Associate Director, Regulatory Affairs – CMC 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

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