Director, Regulatory CMC

Overview

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 , and follow the company on Linked In, X and Facebook. in collaboration with Abb Vie.

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.

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…