PpAbout the Role: /ppProvides strategic regulatory leadership of programs in a therapeutic area, overseeing all regulatory activities across the product lifecycle, and coordinating with cross‑functional partners. /ph3Responsibilities /h3ulliDrive collaboration with Clinical, Quality, Drug Safety Pharmacovigilance, Legal, Government Affairs Public Policy, and Patient Advocacy to integrate regulatory perspectives. /liliDevote significant time to talent and workforce development, and set the tone for the regulatory group from a leadership perspective. /liliPerform due diligence activities and serve as a trusted advisor across the company, recognized as an external expert. /liliMember of the Regulatory Strategy Leadership Team, contributing to strategy development and execution, and strengthening organization capabilities. /liliRepresent regulatory strategy at the therapeutic and Development Market Strategy Team levels, and in enterprise governance forums. /liliProvide hands‑on regulatory oversight for programs from early phase to post‑marketing, including successful leadership of marketing authorization applications to EMA, Swissmedic, and MHRA. /liliOffer guidance on complex regulatory issues to teams and senior management, ensuring a broad understanding of benefits and risks. /liliMaintain productive external relationships with regulators and industry peers to advance company interests. /liliAdvise on translating regulatory requirements into strategy and business opportunity, and consult on regulatory research. /liliDevelop and mentor high‑performing teams and future leaders, fostering accountability, innovation, and cross‑functional alignment. /liliChampion ethical professional behavior and create a respectful work environment. /liliEnsure compliance with all regulatory requirements. /li /ulh3Qualifications /h3ulliBS/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. /liliBroad experience directing a regulatory team through all regulatory strategy considerations for complex programs. /liliEx‑US CTA experience required. /liliExpert‑level knowledge of the regulatory and therapeutic area environment; routinely consulted by regulatory teams. /liliExemplary leadership and influence across functions and levels. /liliProven record of developing high‑performing teams through mentorship and direct supervision. /liliAbility to build consensus, negotiate persuasively, and address disagreements constructively. /liliExperience cultivating a workforce through hiring, promotion, and development aligned with talent needs. /liliHighly effective people‑management skills to mentor, motivate, and influence staff. /liliExcellent verbal and written communication skills for various audiences. /liliPrior US marketing application filing experience required. /li /ulpNeurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment. /p /p #J-18808-Ljbffr