Regulatory Strategy Manager

About the role

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie ) Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities. Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs. Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials. Perform regulatory research and communicate new/emerging regulations to management and project teams. _ Your Contributions (include, but are not limited to): Develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed Provide regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs Develop and manage project timelines for regulatory submissions Lead, coordinate, author, critically review and provide strategic input on regulatory filing documents Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams Develop and maintain standard operating procedures and department working practices Ensures the company is adhering to all applicable government regulations Complete assigned activities with the project team Other duties as assigned

Requirements

• Master's degree in Life/Health Sciences preferred AND 4+ years of related experience OR
• PharmD or PhD AND 2+ years of related experience
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent verbal and written communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Ability to work independently with minim

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