Associate Director, CMC Regulatory Strategy & Submissions

Monte Rosa Therapeutics, Inc.; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls.

You will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority discussions from IND/CTA through NDA/MAA. Based in Basel, this senior role requires a strong cGMP background, ICH knowledge, and a proven track

Qualifications

• Experience leading global CMC regulatory strategies across development stages.
• Authoring and review of CTD modules and summaries for regulatory submissions.
• Strong knowledge of ICH guidelines and cGMP principles.

Responsibilities

• Develop and execute global CMC regulatory strategies for small-molecule programs.
• Author and finalize Module 3 content, QOS, and responses to authorities.
• Act as primary CMC regulatory contact for programs, coordinating input from multiple teams.
• Lead risk assessments and propose mitigation plans with technical teams.
• Support health authority interactions including meetings and information requests.
• Monitor evolving CMC regulatory guidance and advise stakeholders.

Skills

CMC Regulatory Affairs

Regulatory Strategy

Regulatory Writing

Cross-functional Collaboration

Project Management

ICH Guidance Knowledge

Education

Bachelor's in Chemistry or related field

MS/PhD preferred

Tools

eCTD publishing tools

Job description

Monte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls.

You will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority discussions from IND/CTA through NDA/MAA. Based in Basel, this senior role requires a strong cGMP background, ICH knowledge, and a proven track