Vice President Regulatory Affairs

Biopharmaceutical Company | Clinical- to Commercial-Stage About the Company I am partnering with a rapidly growing biopharmaceutical organization focused on advancing innovative therapies for patients with serious and underserved diseases. With multiple late-stage clinical programs and expanding global operations, the company is entering a pivotal phase of growth as it advances toward commercialization. To support this next stage, we are seeking aVice President, Regulatory Affairsto provide strategic leadership across global regulatory strategy and execution. Position Overview TheVice President, Regulatory Affairswill serve as a key member of the executive leadership team, responsible for defining and executing global regulatory strategy across development and commercial programs. This individual will lead regulatory interactions with global health authorities, including the FDA and EMA, while building scalable regulatory infrastructure to support pipeline expansion and future product approvals. This is a highly visible leadership role offering direct influence on corporate strategy, portfolio decisions, and long-term organizational growth. Key Responsibilities Develop and leadglobal regulatory strategyacross clinical and commercial-stage programs Serve as primary regulatory liaison with global health authorities (FDA, EMA, and other agencies) Provide regulatory leadership forINDs, BLAs/MAAs, sNDAs , and lifecycle management activities Advise executive leadership on regulatory risks, timelines, and approval pathways Lead regulatory planning for major milestones includingregistrational filings and approvals Build, mentor, and scale a high-performing Regulatory Affairs organization Partner cross-functionally with Clinical, CMC, Commercial, Quality, and Medical Affairs teams Ensure alignment between global development strategy and regulatory requirements Represent Regulatory Affairs in governance committees and board-level discussions Monitor evolving regulatory landscapes and proactively guide organizational strategy Qualifications Advanced degree preferred (PhD, PharmD, MS, or equivalent scientific discipline) 15+ yearsof Regulatory Affairs experience within biotech or pharmaceutical industry Demonstrated success leadingglobal regulatory strategy through approval Experience interacting directly with FDA and global regulatory agencies Prior leadership experience atSenior Director or VP level Strong understanding of development through commercialization lifecycle Proven ability to operate within fast-paced, growth-stage biotech environments Excellent executive communication and stakeholder leadership skills Why Join Executive leadership visibility and strategic influence Opportunity to shape regulatory strategy across a growing pipeline Collaborative, science-driven culture Competitive executive compensation package includingbonus and equity Hybrid working model in the Boston biotech hub#J-18808-Ljbffr

Created: 2026-03-05