Job Description

Join to apply for the Sr. Director, Regulatory Strategy role at Neurocrine Biosciences

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Join to apply for the Sr. Director, Regulatory Strategy role at Neurocrine Biosciences

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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 are passionate about our people and our mission to relieve suffering for people with great needs.

What We Do

Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to discovering and developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments and a pipeline of clinical-stage compounds. We aim to ease the burden of complex conditions through brave science. For more, visit neurocrine.com and follow us on LinkedIn, X, and Facebook.

About The Role

Responsible for managing and leading regulatory activities for assigned products, ensuring compliance with registration requirements, developing global regulatory strategies, and overseeing submissions and interactions with regulatory authorities. Provides leadership to program teams on global drug development and lifecycle management.

Your Contributions

• Lead regulatory strategies for development projects, including submissions and agency interactions.
• Author and oversee submission documents and prepare for regulatory meetings.
• Develop and implement strategies for regulatory approvals.
• Provide guidance on lifecycle management for commercial products.
• Act as the primary contact with regulatory agencies and represent Neurocrine in interactions.
• Lead regulatory subteams and oversee dossier planning and timelines.
• Review documentation for compliance and accuracy.
• Advise senior management on regulatory strategies and issues.
• Address complex regulatory issues with advanced solutions.
• Partner with stakeholders for science-based decision making.
• Lead continuous improvement in regulatory processes.
• Other duties as assigned.

Requirements

• BS/BA in life sciences or related field with 15+ years in pharma, including regulatory submissions and agency interactions. US marketing experience preferred.
• Master's degree with 13+ years or PhD with 10+ years of relevant experience.
• Extensive managerial experience.

Neurocrine Biosciences is an equal opportunity employer committed to diversity and inclusion. We encourage candidates to apply regardless of experience or qualifications that may not exactly match the outlined requirements.

The annual base salary range is $229,000 - $331,650, with additional bonuses, equity, and benefits including retirement plans, paid leave, and health coverage.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Legal

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