Global Regulatory Policy Director

3 weeks ago

Pasco, Washington, United States Fairway Consulting Group Full time

Job Summary

Fairway Consulting Group is seeking a highly skilled Global Regulatory Policy Director to join our team. As a key member of our organization, you will be responsible for advancing the company's regulatory policy positions among key US and European stakeholders, including the FDA and EMA.

Key Responsibilities

  • Serves as the company subject-matter expert and representative to company's policy strategy development and execution efforts.
  • Advances the company's regulatory policy positions among key US and European stakeholders.
  • Leads in managing the US and EU Regulatory Advisory Groups.
  • Crafts formal responses to relevant regulatory proposals.
  • Develops opportunities to proactively influence pre-identified regulatory policy issues.
  • Assists in preparing for senior executives' meetings and interactions with FDA and EMA.
  • Supports Vice-President Public Affairs US and Head of Public Affairs Europe in integrating regulatory policy and intelligence into legislative and other public affairs workstreams and strategies.
  • Gathers intelligence on US and EU and national regulatory policies, FDA, and EMA guidelines.
  • Drafts clear, consistent, and authoritative documents on new US and EU regulatory policy directives and regulations.
  • Leads working groups to produce comments on draft guidance documents.

Requirements

  • A Master's degree is required with significant experience in the biopharma industry as an effective biotech regulatory expert.
  • Must have an in-depth knowledge of FDA and EMA policies, procedures, decision-making process, and scientific approach.
  • Requires knowledge of CBER/OTP and EU ATMP regulations, relevant to Cell and Gene Therapy Products.
  • Requires experience in monitoring and analyzing regulatory policies, issues, and trends.
  • Experience in representing a company's or industry association's regulatory policy interests in multi-stakeholder forums would be beneficial.
  • Must have the demonstrated ability to strategically assess developing regulatory opportunities and risks and counsel colleagues in real-time.
  • A working knowledge of regulatory issues related to tissue engineering, cell therapy, gene therapy, and gene editing is required.
  • Must be adept at translating complex healthcare terminology into easily understandable information for policymakers.
  • An in-depth understanding of US and EU regulatory policies, procedures, and cross-functional engagement is required.
  • Requires the demonstrated ability to take a leadership role.
  • A proven track record of being innovative and creative; the ability to advance priorities through the various stages of strategic planning as well as implementation is required.
  • Must have an executive presence and gravitas with already established relationships and credibility with regulators.
  • The ability to undertake necessary travel to participate in relevant events is required.
  • Requires outstanding communication skills, both written and oral, including to the most senior levels of leadership.
  • Strong analytical and creative skills are required.
  • The ability to build consensus for ideas both internally and externally.
  • Must have excellent project management and problem-solving skills and ideally have experience in effectively interfacing with regulatory bodies and professional associations in the CGT space.
  • The ability to navigate complex, fast-paced organization and work collaboratively with peers to achieve goals is required.

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