Senior Director, Regulatory Affairs

New Yesterday

Senior Director, Regulatory Affairs - Permanent - Boston, MA
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Join a trailblazing biotech on the cutting edge of science and technology. Senior Regulatory Affairs Leadership Role - Rare Disease Proclinical is working with a well-funded, clinical-stage biotech developing transformative therapies for patients with severe, underserved conditions. With multiple late-stage programs advancing toward registrational milestones, this is a chance to step into a role with real visibility and impact. The opportunity: Reporting to the head of Regulatory Affairs, this hire will be the strategic lead across multiple programs, guiding interactions with health authorities, setting global regulatory strategy, and preparing the organization for submission and launch. With strong support already in place, this role will be the visible face of regulatory at both the governance and cross-functional team levels. Why this role stands out: Lead programs are on track for regulatory filings in the next 18-24 months, with the company preparing for its first commercial launch soon after. Programs already carry expedited and orphan designations, reflecting the strength of the underlying data and science. The team is mission-driven, science-first, and backed by top-tier investors. Ideal profile: Broad experience shaping global regulatory strategy (U.S. & EU) in a biotech setting. Track record of driving filings and engaging with health authorities. Executive presence, with the ability to communicate clearly at governance and leadership levels. Location: Boston area - hybrid (onsite 3 days/week). This is a unique opportunity to join a company at a true inflection point, where regulatory leadership will directly shape the path to approval and launch. If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page. Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
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Location:
Boston, MA
Salary:
$250
Category:
Management And Consultancy

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