Senior Director/Vice President Regulatory Affairs Policy

A leading global biosimilars organization is seeking a Senior Director or Vice President, Regulatory Affairs to join its U.S. leadership team. This individual will serve as a key regulatory spokesperson and thought leader, supporting regulatory strategy for biosimilar products, shaping external policy engagement, and leading strategic interactions with the U.S. Food and Drug Administration (FDA), industry associations, and academic or scientific organizations. This role will play a critical role in advancing biosimilar adoption in the U.S. by aligning product‑specific regulatory strategies with evolving FDA frameworks and broader policy initiatives.

This is a highly visible, externally facing role with the opportunity to shape U.S. biosimilar regulatory policy and influence product approvals and long‑term regulatory strategy. The position is ideally suited for a former FDA leader or senior regulatory policy expert with deep biosimilars expertise.

Key Responsibilities:

FDA & External Regulatory Engagement

• Serve as a primary regulatory interface with the U.S. FDA, including senior‑level engagement related to biosimilar development, approval pathways, and post‑approval considerations
• Lead and support formal and informal interactions with FDA review divisions and policy groups, including preparation and execution of regulatory meetings
• Maintain and leverage strong working relationships across FDA to support regulatory strategy and efficient regulatory decision‑making

Regulatory Policy & Advocacy

• Develop and support regulatory policy strategies that advance U.S. biosimilar adoption and align with broader industry initiatives
• Monitor and interpret FDA guidance, policy trends, and regulatory developments impacting biosimilars and biologics
• Represent the organization in industry associations, biosimilar forums, and working groups (e.g., AAM, BIO)

Product & Portfolio Strategy

• Provide strategic regulatory leadership for product‑specific biosimilar strategies, supporting development, approval, and lifecycle management
• Advise internal teams on regulatory positioning, risk assessment, and FDA expectations
• Partner cross‑functionally with internal stakeholders to ensure regulatory alignment across development, medical, and commercial functions

Thought Leadership & External Collaboration

• Engage with academic institutions, scientific societies, and policy stakeholders to build credibility and influence within the biosimilars ecosystem
• Contribute to external thought leadership efforts, consensus initiatives, and policy discussions that shape the future of the biosimilars landscape
• Act as a senior internal advisor on regulatory policy trends and external engagement strategy

Qualifications

• Advanced degree in biological sciences, pharmaceutical sciences, medicine, or a related field (PhD, PharmD, MD, or equivalent preferred)
• Extensive experience in biosimilars regulatory strategy and policy
• Prior experience at the U.S. FDA strongly preferred, ideally within the Office of Therapeutic Biologics and Biosimilars (OTBB) or closely related biologics review or policy organizations
• Demonstrated senior‑level FDA engagement, with well‑established, credible networks within the Agency
• Deep understanding of biosimilar regulatory pathways and FDA policy frameworks
• Experience engaging with biosimilar or biologics industry associations (e.g., AAM, BIO) or regulatory policy forums
• Experience managing, shaping, or influencing regulatory policy within an organization, government agency, or industry group

Note: This role does not focus on traditional regulatory operations or submission execution. It is a strategic, externally oriented position centered on FDA engagement, biosimilar policy, and regulatory influence.