Assoc. Regulatory CMC Director

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 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.About the Role:Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner focused on development for biologics; small molecules may also be assigned. This is a great opportunity to support our expansion into the Gene Therapy space.Your Contributions (include, but are not limited to):Responsible for the regulatory CMC strategy and execution for assigned commercial and development projects, including significant contributions to IND/CTA preparation, maintenance and update activities, interaction with regulatory agencies, e.g., FDA and EMA, focusing on CMC aspects for scientific areas such as biologics and/or small molecule modalities.Leads development of CMC regulatory plans to ensure optimal product development leading to the earliest possible clinical clearances and/or approvals by relevant regulatory authorities.Provides expertise on global regulatory CMC requirements for multiple scientific areas, such as biologics modalities (peptides, monoclonal antibodies, cell and gene therapy) and/or small molecule program management.Provides expert advice to product development teams on regulatory issues for the planning, compilation, and submission of IND/CTA/MAA/NDA/BLA.May lead interactions and negotiations with regulatory agencies during all stages of development and registration.Leads preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA).Creates, reviews, and edits reports and regulatory submissions.Actively engages with stakeholder groups to help shape science-based regulatory decision-making.May act as regulatory CMC liaison within the company, with partner companies, and contract manufacturers (CMOs) or research organizations (CROs).Other duties as assigned.Requirements:Bachelor's degree in life science and 10+ years of experience in regulatory affairs in the pharmaceutical/biotech industry, with prior project regulatory leadership experience focusing on CMC aspects for small molecules, large molecules, and/or cell/gene therapies.Master's degree in life science and 8+ years of similar experience as noted above.Sound knowledge and experience with biologics (peptides, monoclonal antibodies, or cell and gene therapy) development and knowledge of small molecule CMC development.Familiarity with regulatory guidelines and regulations governing biologics and small molecule CMC topics.Able to critically review regulatory scientific documents across all CMC areas for biologics and small molecule modalities.Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus.Ability to effectively interact and communicate with multiple functions across the organization, including executive management.Requires broad understanding of the processes, procedures, and systems used to accomplish the team's work.Ability to work as part of and lead multiple teams.Good leadership, mentoring skills, and abilities typically leading lower levels and/or indirect teams.Excellent computer skills and problem-solving abilities.Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.Excellent verbal and written communication skills and strong attention to detail.Possess excellent interpersonal skills.Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace and encourage you to apply even if your experience or qualifications don't align exactly with what we have outlined.The annual base salary we reasonably expect to pay is $167,000.00-$241,925.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity-based long-term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage.

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