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.

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:

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• 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

• BS/BA degree in Life/Health Sciences and 8+ years of industry experience of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity. Experience with FDA regulations and ICH guidelines for regulatory submissions OR

• Master's degree in Life/Health Sciences preferred and 6+ years of related experience OR

• PharmD or PhD and 4+ years of related experience

• Ability to work independently with minimal direction, including functional representation within project teams in order to attain group goals

• Thorough understanding of FDA regulations and ICH guidelines for regulatory submissions

• Demonstrated understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge) a plus

• 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

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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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