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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• Partners with key internal stakeholders to establish labeling strategies and regulatory labeling processes and capability for Neurocrine Biosciences' late-stage and marketed products

• Oversee implementation, training and maintenance of labeling processes and, as applicable, labeling-specific systems

• Global Labeling Lead for assigned programs, responsible for core labeling review, approval, archive, and communication. Oversee review and approval process for local/regional labeling in partnership with Regulatory Strategy Leads

• Apply regulatory labeling experience and knowledge for prescription drugs (eg, small molecules, biologics, gene therapy) including, but not limited to core, physician, patient, and device/combination product labeling to ensure internal labeling policies and procedures support development of accurate and compliant labeling

• Establish and implement strategic labeling principles and processes to support development of target product labeling

• Partner with internal stakeholders (Safety, Supply Chain, Law, Regulatory Advertising-Promotion, etc.) for implementation of approved labeling

• Support development of Instructions for Use labeling documents (eg, for Human Factors testing, use in clinical studies)

• Represent Neurocrine Biosciences Regulatory Affairs in labeling industry groups, and with labeling vendors (eg, translations, proof-reading, readability)

• Work with VP Regulatory Affairs (or designee) on regulatory labeling priorities, assisting in the development of regulatory labeling materials (eg, standards, templates, metrics)

• Partners with Regulatory Policy to develop impact assessments and summaries for revised / new labeling regulations, guidance and initiatives

• Works with VP Regulatory Affairs to educate relevant internal audiences on labeling requirements and processes

• Partners with Regulatory Affairs leadership and supports VP Regulatory Affairs with strategic planning and goal setting for the department

• Other duties as assigned

• BS/BA degree Regulatory Sciences, Business, Political Science, or related Field and 10+ years related work experience in Public Policy focused role OR

• Master's Degree and 8+ years of similar experience noted above

• Demonstrates proficiency or knowledge in regulatory labeling strategy and operations, including drugs, combination products, and target labeling

• Facilitates cross-functional labeling meetings, partnering with relevant subject matter experts to develop accurate and compliant labeling

• Ability to work as part of and lead multiple departmental and cross-functional initiatives

• Good leadership and cross-functional partnership skills

• Excellent computer and document management skills

• Excellent written and verbal communications, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on drug development and department/company, able to integrate analysis of regulatory impact with fundamental understanding of relevant issues and development of recommendations/solutions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Strong understanding of US and EU regulations and oversight of prescription drugs

• Demonstrated understanding of core and regional/local labeling policies and processes

• Self-starter, highly skilled in verbal and written communications with demonstrated ability to convey - in a clear and compelling manner - important messages to internal and external parties with different backgrounds and interests, including internal tactical teams and senior management

• Track record of working in a collaborative manner with a range of internal and external stakeholders

• Proven ability to build effective relationships with internal and external constituencies, including senior business leaders, regulatory officials, counterparts at other companies, and industry representatives

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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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