Specialist, Regulatory Operations

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, but few options. What We Do: 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: Responsible for the preparation of documentation for products that are subject to regulatory approval. Uses a controlled documentation system, maintains technical and non-technical documentation for regulated products or product components. _ Your Contributions (include, but are not limited to): Supports multiple projects, may lead smaller efforts, to prepare submissions to regulatory authorities, with general supervision (e.g. clinical trial applications, initial IND and maintenance submissions, annual reports, expedited safety reports) Works with seniors specialists to perform quality checks of assigned regulatory submission documentation and electronic publishing output. Ensures information captured is complete and accurate and meets the expectations of applicable regulatory bodies Extracts and summarizes product information for submission to regulatory agencies or to fulfill other internal or external requests. May analyze and provide recommendations as needed May review, suggest and support implementation of business and process improvements May prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials Imports submissions into document management system Supports regulatory initiatives and monitors regulatory submission timelines and deliverables Learns and keeps abreast of updates to regulatory guidance, laws, and best practices related to job functionality Other duties as assigned Requirements: BS/BA degree in a scientific field and 2 years of relevant experience in the pharmaceutical or biotechnology industry OR Master’s degree in a scientific field and Some experience as noted above OR Working knowledge of electronic submissions and documentation systems Ability to identify and seek needed information/research skills 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 communications (written/verbal), problem-solving, analytical thinking skills Ability to meet deadlines Good project management skills Must be detail oriented and have strong organizational skills Ability to work independently with minimal direction Have good interpersonal skills and be able to deal effectively with personnel at different organizational levels #LI-SA1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.