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EPM Scientific · 1 week ago

Senior Director/Vice President Regulatory Affairs Policy

United States

Full-time

Remote

Director/Executive

$250K/yr - $350K/yr

EPM Scientific is a leading global biosimilars organization seeking a Senior Director or Vice President of Regulatory Affairs to join its U.S. leadership team. This role will serve as a key regulatory spokesperson, supporting regulatory strategy for biosimilar products and leading strategic interactions with the U.S. FDA and other stakeholders.

BiotechnologyRecruiting

Hiring Manager

Sophia Rapp

Responsibilities

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

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)

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

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

Qualification

Biosimilars regulatory strategyFDA engagementRegulatory policy developmentAdvanced degree in sciencesIndustry associationsThought leadershipCross-functional collaboration

Required

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