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Reporting to the Chief Executive Officer, the Senior Vice President, Regulatory Affairs & Quality Assurance will serve as a strategic member of the senior leadership team, leading the regulatory vision and quality foundation for a clinical-stage antifungal portfolio. This role is responsible for defining and executing the global regulatory strategy and approval pathway for turletricin and additional pipeline assets, guiding programs from Phase 2 through Phase 3, registration, and launch readiness. The position will lead regulatory interactions with FDA, EMA, and other global health authorities, assess and pursue expedited regulatory pathways and designations, and provide strategic input on labeling, lifecycle management, and registration planning across worldwide markets.
The successful candidate will drive Phase 3 and registration readiness by developing regulatory, quality, CMC, and operational strategies aligned with major marketing applications, including NDA, MAA, and ex-U.S. submissions. This leader will partner closely with Clinical, Nonclinical, CMC, Program Leadership, Corporate Development, and external development partners to ensure development plans support global registration objectives. The role also includes shaping strategies related to non-dilutive government funding and public-private partnerships while ensuring regulatory and quality compliance expectations are met across government-supported programs.
In addition, the Senior Vice President will build and lead a phase-appropriate GxP quality management system that scales from Phase 2 through commercial readiness, including oversight of inspection readiness, audits, quality agreements, CAPA management, change control, and vendor quality oversight within an outsourced operating model. Candidates should bring 15+ years of progressive regulatory affairs and quality experience, including at least 10 years in executive leadership roles within biotechnology or biopharmaceutical organizations. A bachelor's degree in a scientific discipline is required, with an advanced degree preferred. Direct experience leading regulatory strategy, expedited approval pathways, FDA interactions, NDA/MAA submissions, quality systems development, and inspection readiness is required. Experience with government-funded development programs, anti-infective or infectious disease products, and CMC regulatory affairs is preferred.
The anticipated base salary range for this position is $325,000 to $375,000 annually. This role is also eligible for a performance-based bonus tied to company and individual objectives and offers a comprehensive benefits package, including medical, dental, and vision coverage, HSA contributions, health and wellness reimbursement, unlimited PTO, and a 401(k) plan with company matching. This is a good faith estimate of the compensation expected to be offered at the time of hire. This position is hybrid/remote, with a preference for candidates based in the Boston area.