Our client is a biotechnology trade association focused on cell and gene therapies. They have asked us to assist them in their search for a Senior Director, Global Regulatory Policy.   Major tasks and responsibilities include:

• Serves as the company subject-matter expert, and in certain forums representative to company’s policy strategy development and execution efforts as coordinated by Global Public Affairs particularly advocacy and policy, and work with member organizations’ US and EU regulatory science teams to identify and align on regulatory policy goals and valued scientific exchange programs which result in guidance or amplification on critical FDA and EMA processes and practices.
• Advances the company’s regulatory policy positions among key US and European stakeholders, including the FDA and EMA.
• In coordination with relevant member company Chairs/Vice-Chairs, leads in managing the US and EU Regulatory Advisory Groups.
• In coordination with Global Public Affairs and relevant Advisory Group Chairs/Vice-Chairs, crafts formal responses to relevant regulatory proposals put forward by either regulatory bodies (e.g., FDA, EMA) and/or by NGOs to strategically achieve the best pathway forward to advance strategic objectives.
• In conjunction with the appropriate company Advisory Groups, develops opportunities to proactively influence pre-identified regulatory policy issues in support of patient centric mission and goals.

• Assists in preparing for senior executives’ meetings and interactions with FDA and EMA. Acts as a resource by member organizations on the interpretation of existing guidance and how they can be used to support development of products.

• 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.
• Gather intelligence on US and EU and national regulatory policies, FDA, and EMA guidelines, with particular focus on company strategic objectives. Communicates timely and actionable regulatory news, insights and intelligence to member organizations and relevant internal audiences.
• Drafts clear, consistent, and authoritative documents on new US and EU regulatory policy directives and regulations, input to FDA and EMA (or other relevant authorities or institutions’) consultations. Leads working groups to produce comments on draft guidance documents.
• In coordination with Head of Global Communications, acts as the Alliances regulatory subject matter expertise by engaging trade press.
• In coordination with Global Public Affairs, advance the regulatory policy agenda through engagement in multi-stakeholder forums for scientific and regulatory exchange.

We seek candidates with the following qualifications:

• 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, experience in working at FDA or EMA is a plus.
• Requires knowledge of CBER/OTP and EU ATMP regulations, relevant to Cell and Gene Therapy Products. Experience with regulatory submissions would be beneficial.
• 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.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.