Associate Director, Regulatory Affairs - Small Molecule Strategy

Overview :

Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to support the global development and approval of our innovative therapies.

Responsibilities :

• The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals.
• Oversee 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 and manage FDA and Health Authority interactions with FDA and global health authorities, including meetings, teleconferences, and written correspondence.
• 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.
• Maintain working knowledge of laws, guidance, and requirements to assigned programs, in addition to general regulatory knowledge.
• Additional duties and responsibilities as required.

Qualifications :