Executive Director, Regulatory Strategy - #48191

Who We Are

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About The Role

Provides 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 (eg, 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.

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Your Contributions (include, But Are Not Limited To)

• Key member of the Regulatory Strategy Leadership Team driving the development and execution on regulatory strategies and strengthening the organization’s capabilities and readiness to deliver on the company’s business priorities while enabling long-term growth
• Represents regulatory strategy at the TA and Development & Market Strategy Team levels, as well as other enterprise level governance forums and corporate initiatives
• Provide 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 MHRA
• Provides guidance on complex regulatory issues to teams & senior management, ensuring broad understanding of benefits and risks of different regulatory strategies
• Develops and maintains productive external relationships (eg, with regulators, peers at other companies) to advance company interests
• Consulted on regulatory research conducted by other team members; provides advice and suggestions for further areas of inquiry
• Advises on translating regulatory requirements into strategy and business opportunity
• Develops and mentors high-performing teams and future leaders, fostering accountability, innovation, and cross-functional alignment
• Champions ethical professional behavior; creates conditions for a productive and respectful work environment
• Ensures compliance with regulatory requirement
  
  

Requirements

• BS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience OR OR
• Master's degree preferred AND 15+ years of related experience as note above OR
• PhD AND 12+ years of related experience
• Broad 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 required
• Possesses 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 environment
• Exemplary leadership skills, including proficiency in influencing across functions & levels in the organization
• Proven record of developing high-performing teams through informal mentorship and direct supervisory relationships
• Demonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively; a skilled diplomat
• Cultivates a workforce through hiring, promotion, and staff development that is well-aligned with current and emerging talent needs
• Possesses highly effective people management skills with the ability to mentor, motivate, and influence staff to achieve goals
• Excellent verbal and written communication skills including the ability to convey information to audiences with a wide range of sophistication
• 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, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.