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, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Performs the preparation of submissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports)

• Conducts reviews 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

• Compiles regulatory filing documents and maintain computerized files to support all documentation systems

• Serves 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

• Ensures 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

• 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 knowledge)

• Demonstrated 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

• Understands key business drivers and uses this understanding to accomplish work

• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas

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

• Ability to work as part of a team; may train lower levels

• Excellent computer skills

• Strong communications, problem-solving, analytical thinking skills

• Detail oriented yet can see broader picture for department

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Strong project management skills

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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