Director, Regulatory Strategy- Gene Therapy

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 leading 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, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, 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. About the Role: Direct regulatory activities for assigned development products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements global regulatory strategies, ensures timely preparation, review and submission of documents to regulatory authorities, collaborates with development partners, and maintains compliance with applicable regulatory requirements. The successful candidate will have practical knowledge and experience to provide guidance to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for biologic (gene therapy, other biologics) and small molecule compounds from the preclinical stage through the initial marketing application, and life cycle management. Your Contributions (include, but are not limited to): Responsible for the regulatory leadership of one or more development projects with a focus on gene therapies (other biologics or small molecules may also be assigned), including responsibility for regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies. Authoring and preparation of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings. Develops regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities. Provides strategic guidance on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTA and NDA/MAA. Serve as the designated program regulatory health authority contact. Represents the company by leading interactions with regulatory agencies during all stages of development, registration and commercialization. Oversee development of dossier filing plan and associated regulatory activity timelines. Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents. Provide critical review of all documentation supporting regulatory applications; ensure compliance with internal data standards and regulatory authority submission requirements. Actively engages with stakeholder groups to help shape science based regulatory decision making. Acts as strategic regulatory liaison with partner companies. Requirements: BS/BA degree in life sciences or related field and 12+ years of experience in Pharmaceutical industry, including drug development experience with demonstrated success in regulatory authority submission strategy, execution and health authority interaction. Prior US marketing application filing experience preferred; Ex-US experience strongly preferred. Experience in writing and leading regulatory documents (e.g., meeting requests/briefing book activities). Master's degree in life sciences or related field and 10+ years of related experience. PhD in life sciences or related field and 7+ years of related experience. Previous managerial experiences also required. Competence in writing and leading regulatory documents (eg, meeting requests/briefing book activities). Detailed knowledge of FDA/EMA/ICH regulations and guidance for drug development, preparation and management of IND/CTA/BLA/NDA/MAA applications. Ability to critically review regulatory scientific documents across the non-clinical and clinical disciplines. Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization. Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively. Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact. Sound knowledge and experience with biologics (gene therapy, other biologics) development. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access). Strong attention to detail and excellent verbal and written communication skills. Effective people management skills. Strong negotiation and influencing skills. 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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