Regulatory Affairs Director

3 weeks ago

Boston, Massachusetts, United States Fairway Consulting Group Full time

Job Summary:

Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global regulatory agencies.

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. Ensure 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 mitigate effectively.
  • Contribute 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.

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