Director, Regulatory Affairs – Global Regulatory Strategy
$180,000–$245,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Develop and lead global regulatory strategies for assigned programs from early development through approval and lifecycle management, ensuring alignment with corporate goals and evolving regulatory expectations. Prepare, submit, and maintain regulatory applications including INDs, CTAs, marketing applications, and Annual Reports while representing Regulatory on cross-functional product teams. Lead regulatory interactions with global health authorities such as the FDA, EMA, and PMDA, and manage third-party vendors to ensure successful execution. Maintain regulatory files and databases, track commitments, and support the development of processes, SOPs, and work instructions. Requires minimum of 12 years of global regulatory experience with a focus on immunology. Monte Rosa Therapeutics is seeking a strategic Director to drive development programs across our portfolio.
Required Qualifications
- Global regulatory experience
- Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry
- Global regulatory strategy experience
- Direct involvement with US, EU and international regulatory submissions and strategy
- Demonstrated experience leading health authority meetings, including with the FDA, EMA, PMDA
- Strong understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, etc.)
Desired Qualifications
- Bachelor's degree in health sciences or related field, or an advanced degree is preferred
- Immunology background
- CMC experience
- Experience in immunology or cardiovascular therapeutic area
- CMC regulatory experience or strong working knowledge
- Ability to build and maintain effective working relationships with internal and external stakeholders
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