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Regulatory Affairs Director

2 months ago

Boston Massachusetts, United States Monte Rosa Therapeutics, Inc Full time

Job Summary:

Monte Rosa Therapeutics, Inc. 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.

Key Responsibilities:

  • Develop and implement regulatory strategies to support the global development and approval of our innovative therapies.
  • 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.
  • Maintain regulatory files and database, track regulatory commitments, and support 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.

Qualifications:

  • 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.
  • 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.