Executive Director, Regulatory Affairs Strategy

Regulatory/QA Group              ·                Hybrid            ·           Full-time

Remote Type: Hybrid
Time Type: Full time
Date Posted: June 1, 2023
Job Requisition ID: R3448

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:

Be a part of our success! You will be responsible for the strategic regulatory leadership of commercial and/or development projects leading to successful life-cycle management, product development, preparation and approval of IND/CTA, MAA and NDA/BLA submissions in a timely and efficient manner. Oversee and direct all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develop and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc. Provide counsel to and manages the regulatory team. Ensure timely preparation of organized and scientifically valid applications. Provide expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Flex your leadership and engagement style as you guide, mentor and help coach others to success!

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

• Responsible for the regulatory leadership of one or more development projects, including responsibility for global regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies
• Develops integrated global regulatory strategies to ensure the earliest possible marketing approvals by FDA, HPB, European and other regulatory authorities
• For commercial products, provides regulatory guidance on all aspects of life-cycle management including strategic label development, safety label changes and regulatory management of the product
• Provides strategic guidance on global regulatory requirements to management and project teams
• Provides guidance to senior management and department VPs and directors within Research, Preclinical and Clinical Development areas on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTAs and NDA/BLA/MAAs
• Provides strategic regulatory guidance for global product development, proposed claims, clinical endpoint selection and labeling
• Represents the company by leading interactions and negotiations with regulatory agencies during all stages of development, registration and commercialization
• Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)
• Reviews and approves non-clinical and clinical study reports and regulatory submissions
• Actively engages with stakeholder groups to help shape science based regulatory decision making
• Acts as strategic regulatory liaison with partner companies
• Leadership of a team of regulatory strategy professionals
• Selects, develops and evaluates personnel to ensure the efficient operation of the function
• Other duties as assigned

Requirements:

• BS/BA degree in a life science and 17+ years of regulatory affairs in the pharmaceutical/biotech industry. Prior project regulatory leadership experience from pre-clinical through clinical phase 3 studies, including detailed knowledge of FDA regulations and guidances for drug development, preparation and management of IND applications and prior leadership experience with NDA preparation and preferably, negotiation to marketing approval. Prior regulatory experience of project leadership, negotiation with and conduct of meetings with the FDA and preparation of IND/CTA and NDA/MAA submissions leading to product marketing authorization. Effective people management skills and experience OR
• Master’s degree preferred and 15+ years of related experience, OR
• PhD and 12+ years of related experience OR
• Extensive previous leadership experiences also required
• Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred
• Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications
• Excellent interpersonal and communication skills and will be required to effectively interact and communicate with multiple functions across the organization, including executive management
• Ability to critically review regulatory scientific documents across the non-clinical and clinical disciplines
• 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
• Outstanding written, verbal and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across the organization
• 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

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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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The annual base salary we reasonably expect to pay is $215,200.00-$355,100.00. 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.

Please click here to apply.