Senior CMC Regulatory Lead – Small Molecules

Monte Rosa Therapeutics; Basel; On-site; CHF 190,000 - 270,000; Full time

Job summary

Monte Rosa Therapeutics seeks an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies, author submission content, and represent CMC in health authority interactions. You will partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure robust regulatory filings.

The role requires strong technical CMC knowledge, ICH guidelines, and the ability to operate independently in a fast-paced, clinical-stage environment.

Qualifications

• Minimum 8 years progressive experience in CMC Regulatory Affairs.
• Direct authorship of Module 3 content for small-molecule programs desired.
• Experience preparing IND/CTA submissions; involvement in NDA/MAA/BLA CMC submissions is highly desirable.
• Strong working knowledge of ICH guidelines, FDA/EMA CMC requirements, and cGMP principles.
• Experience collaborating with CDMOs/CMOs in outsourced manufacturing models.
• Excellent scientific writing and clear regulatory narrative skills.

Responsibilities

• Develop and execute global CMC regulatory strategies across development stages.
• Author, review, and finalize high-quality CMC submission content (Module 3, 2.3, 3.2.S, 3.2.P).
• Serve as primary CMC regulatory point of contact for programs.
• Lead CMC regulatory risk assessments and mitigation planning.
• Support health authority interactions (FDA, EMA, others) and information requests.
• Monitor evolving CMC regulatory guidance and advise on program implications.
• Contribute to internal CMC SOPs, templates, and lifecycle management.

Skills

CMC regulatory affairs

Regulatory strategy

Technical writing

Cross-functional collaboration

Submission publishing (eCTD)

GMP/ICH knowledge

Education

Bachelor's in Chemistry or Pharmaceutical Sciences

MS or PhD preferred

Tools

eCTD submission tools

Job description

Monte Rosa Therapeutics seeks an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies, author submission content, and represent CMC in health authority interactions. You will partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure robust regulatory filings.

The role requires strong technical CMC knowledge, ICH guidelines, and the ability to operate independently in a fast-paced, clinical-stage environment.