Sr. Director, Regulatory Strategy

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:

Responsible for management and leadership of regulatory activities for assigned commercial and/or development products. Accountable for ensuring alignment and compliance with local and regional registration requirements as well as with company policies. Oversees the development and implementation of global regulatory strategies, ensures timely preparation, review and submission of documents to regulatory authorities, collaborates with development partners, and drives compliance with applicable regulatory requirements. Provides leadership and direction to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and lifecycle management.

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Your Contributions (include, but are not limited to): 

• Responsible for the regulatory leadership of one or more development projects, including responsibility for global regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies 

• Authoring and oversight of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings 

• Oversees the development and implementation of regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities 

• Accountable for the strategic oversight on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTA and NDA/MAA, ensuring effective integration of global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents 

• For commercial products, provides regulatory guidance on all aspects of lifecycle management including strategic label development, safety label changes and regulatory management of the pro