About the Role:Provides strategic regulatory leadership of programs in a therapeutic area, overseeing all regulatory activities across the product lifecycle, and coordinating with cross‑functional partners.ResponsibilitiesDrive collaboration with Clinical, Quality, Drug Safety & Pharmacovigilance, Legal, Government Affairs & Public Policy, and Patient Advocacy to integrate regulatory perspectives.Devote significant time to talent and workforce development, and set the tone for the regulatory group from a leadership perspective.Perform due diligence activities and serve as a trusted advisor across the company, recognized as an external expert.Member of the Regulatory Strategy Leadership Team, contributing to strategy development and execution, and strengthening organization capabilities.Represent regulatory strategy at the therapeutic and Development & Market Strategy Team levels, and in enterprise governance forums.Provide hands‑on regulatory oversight for programs from early phase to post‑marketing, including successful leadership of marketing authorization applications to EMA, Swissmedic, and MHRA.Offer guidance on complex regulatory issues to teams and senior management, ensuring a broad understanding of benefits and risks.Maintain productive external relationships with regulators and industry peers to advance company interests.Advise on translating regulatory requirements into strategy and business opportunity, and consult on regulatory research.Develop and mentor high‑performing teams and future leaders, fostering accountability, innovation, and cross‑functional alignment.Champion ethical professional behavior and create a respectful work environment.Ensure compliance with all regulatory requirements.QualificationsBS/BA degree in life sciences (or equivalent) plus 17+ years of biopharma and/or regulatory experience with prior leadership, or a Master's degree with 15+ years, or a PhD with 12+ years of related experience.Broad experience directing a regulatory team through all regulatory strategy considerations for complex programs.Ex‑US CTA experience required.Expert‑level knowledge of the regulatory and therapeutic area environment; routinely consulted by regulatory teams.Exemplary leadership and influence across functions and levels.Proven record of developing high‑performing teams through mentorship and direct supervision.Ability to build consensus, negotiate persuasively, and address disagreements constructively.Experience cultivating a workforce through hiring, promotion, and development aligned with talent needs.Highly effective people‑management skills to mentor, motivate, and influence staff.Excellent verbal and written communication skills for various audiences.Prior US marketing application filing experience required.Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment.
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