About the RoleProvides strategic regulatory leadership of programs in a therapeutic area (TA), overseeing and directing all regulatory activities across the entire product lifecycle. Drives collaboration with cross‑functional partners (Clinical, Quality, Drug Safety & Pharmacovigilance, Legal, Government Affairs & Public Policy, Patient Advocacy) to ensure consideration of regulatory perspectives. Devotes significant time to talent and workforce development. Sets the tone for the group from a leadership perspective. Performs due diligence activities. Serves as a trusted advisor across the company and may be recognized as an expert externally.Your Contributions (include, but are not limited to)Key member of the Regulatory Strategy Leadership Team driving the development and execution of regulatory strategies and strengthening the organization’s capabilities and readiness to deliver on the company’s business priorities while enabling long‑term growthRepresents regulatory strategy at the TA and Development & Market Strategy Team levels, as well as other enterprise level governance forums and corporate initiativesProvide strategic regulatory oversight and hands‑on execution for a variety of programs from early phase to post‑marketing including successful leadership of marketing authorization applications to EMA, Swissmedic, and MHRAProvides guidance on complex regulatory issues to teams & senior management, ensuring broad understanding of benefits and risks of different regulatory strategiesDevelops and maintains productive external relationships (eg, with regulators, peers at other companies) to advance company interestsConsulted on regulatory research conducted by other team members; provides advice and suggestions for further areas of inquiryAdvises on translating regulatory requirements into strategy and business opportunityDevelops and mentors high‑performing teams and future leaders, fostering accountability, innovation, and cross‑functional alignmentChampions ethical professional behavior; creates conditions for a productive and respectful work environmentEnsures compliance with regulatory requirementsRequirementsBS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience OR ORMaster’s degree preferred AND 15+ years of related experience as note above ORPhD AND 12+ years of related experienceBroad experience and expertise directing a regulatory team in successfully navigating all regulatory strategy considerations for a diverse array of complex programs. Ex‑US CTA experience requiredPossesses expert‑level knowledge of the regulatory and TA environment; routinely consulted by regulatory teams to advise on recommended courses of action in response to changes in the environmentExemplary leadership skills, including proficiency in influencing across functions & levels in the organizationProven record of developing high‑performing teams through informal mentorship and direct supervisory relationshipsDemonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively; a skilled diplomatCultivates a workforce through hiring, promotion, and staff development that is well‑aligned with current and emerging talent needsPossesses highly effective people management skills with the ability to mentor, motivate, and influence staff to achieve goalsExcellent verbal and written communication skills including the ability to convey information to audiences with a wide range of sophisticationPrior US marketing application filing experience requiredNeurocrine Biosciences is an EEO/Disability/Vets employer.
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