Director, Regulatory CMC

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.

What We Do:

Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. The ideal candidate will have experience in biologics and able to manage this space on behalf of Neurocrine. Help to carve out workflows and SOP’s for Biologics Guidelines with the FDA as well as strategies to take for our biologic’s programs. Someone with experience and/or an understanding of combination devices would be fantastic.

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Your Contributions (include, but are not limited to):

• Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects

• Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities

• Provides strategic guidance on global regulatory CMC requirements to management and project teams

• Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA

• May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration

• Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)

• Reviews and approves reports intended for use in regulatory submissions

• Actively engages with stakeholder groups to help shape science based regulatory decision making

• Acts as regulatory CMC liaison with partner companies and contract manufacturers

• Provides expertise in translating regulatory requirements into practical, workable plans

• Interacts with regulatory agencies for assigned projects

• Selects, develops and evaluates personnel to ensure the efficient operation of the function

• Other duties as assigned

Requirements:

• BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies. Leadership experience in preparation and preferably, negotiation to marketing approval in major markets is desired. OR

• Master's degree preferred AND 10+ years similar experience noted above OR

• PhD preferred AND 7+ years similar experience noted above OR

• Extensive previous managerial experiences also required

• Acts as a "trusted advisor" across the company and may be recognized as an external expert

• Provides strategy, vision and direction regarding issues that may have company-wide impact

• Requires in-depth knowledge of the functional area, business strategies, and the company’s goals

• Possesses industry-leading knowledge

• Ability to apply advanced analytical thought and judgment

• Strong leadership, coaching, employee development skills

• Ability to influence others with or without authority at all levels of the organization

• Proactive, innovative, with excellent problem-solving skills

• Ability to work in a cross functional team and matrix environment

• Excellent written, presentation, and verbal communication skills

• Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies

• Detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA

• Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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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The annual base salary we reasonably expect to pay is $187,900.00-$256,000.00. 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 35% 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 in accordance with the terms and conditions of the applicable plans.