Sr. Specialist, Regulatory Strategy

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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• 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

• 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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