Monte Rosa Therapeutics · 1 week ago
Director, Regulatory Affairs - Global Regulatory Strategy
Boston, MA
Full-time
Onsite
Director/Executive
12+ years expMonte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across their development programs, focusing on immunology. The ideal candidate will develop and execute regulatory strategies that support global product development and registration, ensuring compliance with regulatory requirements.
BiotechnologyMedicalTherapeutics
Responsibilities
Develop and lead global regulatory strategies for assigned programs from early development through approval and lifecycle management
Ensure regulatory strategies align with corporate goals and evolving regulatory expectations
Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents
Lead regulatory interactions and meetings with global health authorities, including FDA, EMA, and other major agencies
Ensure compliance with global regulatory requirements and guidelines, including FDA, EMA, and other regulatory authorities
Represent Regulatory on cross-functional product team and provide strategic regulatory guidance and support to achieve product development objectives
Collaborate with internal and external stakeholders, manage and oversee third-party vendors and consultants to ensure high-quality submissions, and successful execution of regulatory strategies
Responsible for the maintenance of regulatory files and database, tracking regulatory commitments, and supporting the development of processes, SOPs, work instructions, and other controlled documents
Additional duties and responsibilities as required
Qualification
Required
Bachelor's degree in health sciences or related field, or an advanced degree is preferred
Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry
Global regulatory strategy experience is required, including 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.)
Ability to build and maintain effective working relationships with internal and external stakeholders
Preferred
Global regulatory experience is required, and immunology background is preferred
Experience in immunology or cardiovascular therapeutic area is preferred
CMC experience is a plus
Bachelor's degree in health sciences or related field, or an advanced degree is preferred
Company
Monte Rosa Therapeutics
Monte Rosa Therapeutics is a biotechnology company that develops cancer therapeutics that modulate protein degradation pathways.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$648.5MKey Investors
Avoro Capital AdvisorsAisling Capital
2026-01-08Post Ipo Equity· $300M
2024-05-15Post Ipo Equity· $100M
2023-10-26Post Ipo Equity· $25M
Leadership Team
S
Sharon Townson
Chief Scientific Officer
Recent News
2026-01-11
2026-01-09
BioWorld Financial Watch
2026-01-09
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