Specialist, Regulatory Strategy - San Diego (Onsite)

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Under direct supervision, assist with preparation of submissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports)

• Conducts review of clinical regulatory documents. Performs quality checks of submission documentation and publishing output

• Updates and maintains logs, databases and catalogues of regulatory compliance information

• Coordinates the review and revision procedures, specifications, and forms

• Assists in compiling regulatory filing documents and maintain computerized files to support all documentation systems

• Under direct supervision, may serve as Regulatory Strategy department contact for internal company projects or program activities

• Responsible for initiating and maintaining program Smartsheet tools for timeline tracking, submission deliverable tracking and program plans as assigned

• Ensure quality, consistency, completeness and accuracy for all regulatory submissions

• Review investigator packages and authorize drug shipments to clinical sites

• Performs other job related duties as assigned

• The ideal candidate will live in the San Diego County Area.

• BS/BA degree and 2+ years of relevant experience

• Master's degree and some related experience

• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers

• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills

• Comfortable with tools and processes that support work conducted by functional area

• Ability to work as part of a team

• Strong computer skills

• Good communications, problem-solving, analytical thinking skills

• Detail oriented

• Ability to meet deadlines

• Good project management skills

• 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

• Understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge)

• Has strong working knowledge of US FDA and Ex-US ICH drug development regulatory guidelines to ensure compliance with local and regional requirements, as well as with company policies

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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.

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