Director, Regulatory Affairs – Global Regulatory Strategy

Job description

Overview Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our 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. This role requires strong regulatory knowledge, leadership skills, and the ability to work effectively in a cross-functional environment. Global regulatory experience is required, and immunology background is preferred. CMC experience is a plus. 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...