Senior CMC Regulatory Strategist – Small Molecules

Monte Rosa Therapeutics, Inc; Basel; Vor Ort; CHF 180.000 - 230.000; Vollzeit

Zusammenfassung

Monte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure compliant, high-quality filings.

You will drive Module 3 content, quality summaries, and responses while engaging with FDA/EMA and other regulators.

Qualifikationen

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field; MS/PhD preferred.
• 8+ years of progressive experience in CMC Regulatory Affairs within biotech/pharma, including Module 3 content for small-molecule programs.
• Experience preparing IND/CTA submissions and involvement in NDA/MAA/BLA CMC submissions is highly desirable.
• Strong knowledge of ICH guidelines, FDA/EMA CMC requirements, and cGMP principles.
• Experience collaborating with CDMOs/CMOs and cross-functional teams in outsourced manufacturing.
• Excellent scientific writing, document review, and communication skills.
• Strong project management skills with multiple submissions and timelines in fast-paced settings.
• Experience with electronic submission publishing tools and eCTD structure and lifecycle management.

Aufgaben

• Develop and execute global CMC regulatory strategies for small-molecule drug substances and products across all development phases.
• Author, review, and finalize CMC submission content, including CTD Module 3, Module 2.3 QOS, IMPD, and regulatory responses.
• Serve as primary CMC regulatory contact for programs, coordinating input from Process Chemistry, Analytical Development, Drug Product, QA, QC, and CMOs.
• Lead CMC regulatory risk assessments, identify gaps, and propose mitigations with technical teams.
• Support health authority interactions (FDA, EMA) including pre-IND and Type B/C meetings, and information requests.
• Monitor evolving global CMC guidance and advise stakeholders on implications for programs.

Kenntnisse

CMC Regulatory Affairs

Module 3 authoring

IND/CTA submissions

ICH guidelines

CDMOs/CMOs collaboration

Scientific writing

Project management

eCTD/submission publishing

Ausbildung

Bachelor's degree in Chemistry or related field

MS or PhD preferred

Tools

eCTD publishing tools

Jobbeschreibung

Monte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure compliant, high-quality filings.

You will drive Module 3 content, quality summaries, and responses while engaging with FDA/EMA and other regulators.