Sr. Specialist, 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:

Join our team of experts as a Sr. Specialist, Regulatory Strategy! Take the lead in preparing document packages for regulatory submissions, ensuring compliance with local and regional registration requirements and company policies. Stay ahead of regulatory changes, maintain tracking systems, and recommend strategies for swift clinical trial approvals. Be the go-to contact for internal projects and program activities. Shape the future of regulatory strategy with us.

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

• As a Regulatory Affairs Specialist where you will play a pivotal role in preparing and submitting critical documents to regulatory authorities with precision and finesse

• You’ll have the opportunity to ensure that all regulatory submissions are of the highest quality, accuracy, and completeness, while also maintaining compliance information and acting as a key contact for internal company projects

• Utilize your keen attention to detail and dedication to maintaining regulatory standards, you will oversee the review and revision procedures, coordinate program activities, and utilize cutting-edge tools like Smartsheet for seamless timeline tracking

• If you thrive in a fast-paced environment, excel at ensuring consistency and accuracy, and are drawn to the opportunity to make a real impact in the biopharmaceutical industry, we want to hear from you

• Additional duties as assigned

Requirements:

• BS/BA degree and 4+ years of relevant experience OR

• Master’s and 2+ years of related experience OR

• JD or PharmD or PhD and without experience

• Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed

• Strong familiarity with regulatory documents

• Strong familiarity with FDA regulations and ICH guidelines for regulatory submissions

• Thorough understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowled