Director, Regulatory Affairs – Global Regulatory Strategy
MonterosaBoston, Massachusetts, United States
Posted October 23, 2025
180000 - 245000 USD year
Full Time
About the Company
Monterosa Therapeutics is a clinical-stage biotechnology company focused on developing highly selective molecular glue degrader (MGD) medicines for serious diseases including oncology, autoimmune, and inflammatory conditions. Utilizing the QuEEN™ discovery engine, which integrates AI-guided chemistry, structural biology, and proteomics, Monterosa identifies and designs MGDs with unparalleled selectivity, enabling access to a diverse range of validated therapeutic targets. The company boasts an industry-leading pipeline of MGDs, positioning it as a pioneer in precision medicine.
Job Description
Monte Rosa Therapeutics is seeking a strategic Director of Regulatory Affairs to lead global regulatory strategies for immunology programs. The role involves developing, executing, and maintaining regulatory strategies, ensuring compliance with global regulatory requirements, and providing strategic guidance to cross-functional teams. Strong regulatory knowledge and leadership skills are essential.
Requirements
- Bachelor's degree in health sciences or related field, or advanced degree.
- 12+ years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
- Global regulatory strategy experience is required.
- Demonstrated experience leading health authority meetings.
- Strong understanding of regulatory requirements (FDA, EMA, ICH, etc.).
- Experience in immunology or cardiovascular therapeutic area (preferred)
- CMC regulatory experience or strong working knowledge (a plus)
