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.
Responsibilities
* Drive 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.
Qualifications
* BS/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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