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Regulatory Affairs Director

2 months ago

Boston, Massachusetts, United States Fairway Consulting Group Full time
Job Title: Director, Regulatory Affairs

We are seeking a highly experienced Director, Regulatory Affairs to join our team at Fairway Consulting Group. As a key member of our team, you will be responsible for providing strategic regulatory leadership and guidance to project teams, ensuring clinical trials are designed to meet regulatory requirements, and collaborating with various departments to ensure alignment with regulatory requirements throughout the product lifecycle.

Key Responsibilities:
  • Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties.
  • Provides strategic regulatory leadership and guidance to project teams, ensuring clinical trials are designed to meet regulatory requirements.
  • Collaborates with various departments such as R&D, Quality, Clinical, and Manufacturing to ensure alignment with regulatory requirements throughout the product lifecycle.
  • Ensures operations are compliant with applicable FDA, ICH, EMA, and industry standards.
  • Proactively identifies regulatory opportunities and risks and mitigates effectively.
  • Contributes to the development of the overall nonclinical and clinical development strategy by providing regulatory insights and guidance at all stages of product development.
  • Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives.
  • Provides contingencies and alternate approaches to leadership and/or partners to resolve any development program challenges from preclinical (pre-IND) to Phase 1 through approval.
  • Supports the preparation of key health authority submissions and interactions.
  • Assures consistent positions on common issues are presented and drives the development and on-time completion of health authority background documents and responses to inquiries.
  • Develops content and formats for regulatory submissions, such as INDs.
  • Coordinates and prepares responses to requests for information from regulatory authorities.
  • Authors, reviews, and/or edits relevant regulatory documents, e.g., clinical development plans, protocols, informed consent, IBs.
  • Stays abreast of regulatory requirements, trends, and changes and informs senior leadership as necessary.
  • Participates in setting and meeting departmental goals, developing team members, and fostering a culture of excellence.
Requirements:
  • Significant regulatory affairs experience is required.
  • Experience with taking a program through key development milestones with global regulatory bodies is highly preferred.
  • Experience with rare disease, neuromuscular, or neurodegenerative therapies is strongly preferred.
  • Must have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global regulatory agencies.
  • Must have proven success interacting with regulatory bodies.
  • Requires a full functional knowledge of regulatory requirements pertaining to the development and registration of drug products.
  • Must be able to solicit information, persuade others, and shape outcomes favorable to the company's goals and objectives.
  • Must be highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies.
  • Demonstrated project management skills and organizational skills are required.
  • Must be willing to roll up sleeves and be hands-on.
  • Effectively recommends and implements solutions to problems.