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Monte Rosa Therapeutics · 2 months ago

Director, Regulatory Affairs – Global Regulatory Strategy

US-MA-Boston

Full-time

Onsite

Director/Executive

12+ years exp

Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across their development programs, with a focus on immunology. The ideal candidate will be responsible for developing and executing regulatory strategies that support global product development and registration.

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

Global regulatory strategyRegulatory submissionsRegulatory complianceImmunology experienceCMC regulatory experienceStakeholder managementLeadership skillsCross-functional collaboration