Sr. Regulatory Policy Director

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:

Leads the Regulatory Policy function that is responsible for proactively monitoring, analyzing and summarizing developments in regulations, guidance developments impacting pharmaceutical development for Neurocrine Bioscience’s products, pipeline and the patients we serve, primarily for the US. Informs and influences policy matters with external stakeholders, and establishes partnerships with Neurocrine Bioscience’s Government Affairs, Public Policy and Patient Advocacy organizations to support relevant policy matters. Ensures that substantive analysis of US regulatory activities related to prescription drugs are conducted and communicated to relevant stakeholders in Regulatory Affairs, Management and cross-functionally, as needed. Leads the development of regulatory policy positions, written summaries, analyses and supporting materials relevant to the company’s programs and corporate objectives as assigned.

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

• Ensures leadership for Regulatory Policy in assigned areas, focusing on one or more following:

• US regulations, policy and guidance issues impacting development of prescription drugs including, but not limited to:

  • Clinical trials

  • Marketing authorizations and periodic reporting

  • Rare Diseases, Orphan Drug and accelerated/innovative pathways

  • Pediatric drug development

  • Trends and activities related to US health authority regulation of prescription drugs

• Attends/represents Regulatory Affairs at regulatory policy meetings with FDA, Industry, and other government agencies

• Strengthens organization situational awareness and advance company regulatory policy priorities

• Represents Neurocrine Biosciences/Regulatory Affairs interests within trade associations, other formal and/or informal coalitions and FDA/Health Authority working groups

• Establishes partnerships within Regulatory Affairs and QRAMP, and with Neurocrine Biosciences stakeholders, such as, Public Policy, Government