Regulatory Policy Executive Director

Job Description

TITLE: Executive Director, Regulatory Policy

AREA: US Policy and Alliance Development

POSITION SUMMARY:

Reporting to the VP of Policy and Alliance Development, the Executive Director of Regulatory Policy provides leadership, subject matter expertise, and strategic insights and advice on US regulatory policy with the goal of understanding how to effectively operate in the regulatory policy environment and how to advocate for policies favorable to innovative new medicines. This role will coordinate very closely with senior leaders in Regulatory Affairs including the Chief Regulatory and Quality Officer and the U.S. Public Affairs team. They will also provide key insights to ensure that product strategies are informed and optimized to enable rapid development in the evolving regulatory environment. As Vertex's pipeline continues to grow, this position will deliver subject matter expertise on FDA policies that span across modalities (small molecule, gene editing, gene therapy) and medical product types (including device and diagnostics).

Additionally, the Executive Director of US Regulatory Policy will be responsible for anticipating, identifying, and communicating US regulatory policy issues/trends/changes occurring in the regulated environment that have the potential to impact our products. They will be responsible for partnering with internal stakeholders to respond to developments, both independently and through external stakeholders, and work to shape the regulatory environment to advance Vertex's policy goals.

In addition to building and maintaining strong internal relationships Executive Director of U.S. Regulatory Policy will need to maintain a deep external network across stakeholders, including relevant government officials in coordination with Global Regulatory Affairs and US Federal Affairs. This position will be responsible for representing Vertex externally within relevant and high-value multi-stakeholder regulatory forums, such as trade associations, and for internal communication and coordination regarding pertinent developments and opportunities, such as Agency communications and engagements. Established credibility amongst regulatory stakeholders, including FDA, is essential.

KEY RESPONSBILITIES:

• Develop and execute plans that advance Vertex's regulatory policy strategies in support of broader Vertex goals and specifically to address regulatory pipeline needs.
• Provide leadership and direction to internal senior and subordinate Vertex stakeholders, including executive committee members, USPA leadership, and other internal "customers" whose job may be affected by regulatory policy
• Collaborate with US Public Affairs and Global Regulatory Affairs leadership to create and implement a strategic plan for external stakeholder engagement on key policy priorities.
• Actively monitor and analyze the regulatory landscape to anticipate, identify, and communicate trends and developments that could impact Vertex and our pipeline of transformative medicines.
• Communicate in a timely manner regulatory developments, insights, and intelligence to Global Regulatory Affairs and other internal stakeholders, including other global functions and senior leadership.
• Represent Vertex in multi-stakeholder forums including but not limited to: trade associations committees (e.g., BIO), professional associations, workshops, and other high-value opportunities for scientific and regulatory exchange, and ensure such opportunities are maximized by productive and concrete engagement
• Provide thought leadership on US regulatory policy and maintain/develop relationships with key leadership at Health Authorities and other external stakeholders.
• In partnership with relevant internal functions, lead the creation of Vertex's responses to regulatory proposals put forward by formal regulatory bodies (e.g., FDA guidance)
• Responsible and accountable for financial and operating performance of the regulatory policy sub-function
• Assist in preparing for meetings and interactions with FDA to discuss regulatory science topics

COMPETENCIES AND SKILLS:

• Ability to work in an intense, fast-paced, innovative work environment
• Ability to work effectively as part of a global organization with internal executives and subject matter experts as well as with external stakeholders such as government officials and trade-association executives.
• Ability to lead across functions and drive to common goal
• High degree of individual initiative/drive yet team affinity
• Strong verbal/written skills

MINIMUM QUALIFICATIONS:

• Experienced Regulatory Professional with a degree in a scientific discipline such as pharmacy or a biological science, a law degree, or equivalent experience; higher degree preferred.
• Recognized expertise in regulations, guidelines and precedents related to pharmaceutical development for innovative small molecules and biologics; device expertise not necessary, but preferred.
• In-depth understanding of biopharmaceutical R&D lifecycle, and broad, comprehensive knowledge of the functions with a biotechnology company and how they contribute to advancing product development and achieving corporate goals.
• Deep understanding of the pharmaceutical industry, particularly of R&D, Commercialization and Operations, and the global context in which the industry operates.
• Demonstrated ability to proactively shape regulatory frameworks and approaches through active membership in professional societies or trade organizations.
• Skilled communicator and facilitator with the demonstrated ability to represent Vertex as the Company's lead liaison in opening doors for communications; a bridge-builder.
• Deep understanding of the political environment and culture within the FDA and the ability to identify key players to be engaged.
• Experience interacting with senior FDA members at Divisional and policy levels; high level of credibility and respect.

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