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 a 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 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, 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 teams 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 databases, tracking regulatory commitments, and supporting the development of processes, SOPs, work instructions, and other controlled documents.
• Maintain working knowledge of laws, guidance, and requirements related to assigned programs, in addition to general regulatory knowledge.
• Additional duties and responsibilities as required.

Qualifications

• Bachelor's degree in health sciences or related field; an advanced degree is preferred.
• Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
• Hands-on experience in managing the preparation and timely submission of regulatory applications, such as US IND or CTA, is required. Regulatory expedited program submissions, CMC, and EU CTA experience is a plus.
• In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval.
• Strong computer skills, including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet.
• Experience with managing third-party vendors, regulatory operations, and consultants is a plus.
• Ability to build and maintain effective working relationships with internal and external stakeholders.