Senior Specialist, Regulatory Strategy

About the role

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie ) Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Generates, maintains, monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trials applications. May act as Regulatory Strategy department contact for various internal projects or program activities. _ Your Contributions (include, but are not limited to): 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

Requirements

• BS/BA degree AND 4+ years of relevant experience, or OR
• Master's AND 2+ years of related experience, or OR
• JD or PharmD or PhD AND without experience
• 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
• 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
• #LI-SA1
• Neurocrine Biosciences is an EEO/Disability/Vets employer.
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• The annual base salary we reasonably expect to pay is $103,300.00-$141,000.00. Individual pay decisions depend on variou

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