Director, Regulatory Strategy

Neurocrine Biosciences seeks a Director of Regulatory Strategy to lead regulatory activities for development products across preclinical through commercialization stages. The role involves directing regulatory strategy, preparing submissions to health authorities, collaborating with internal and external partners, and representing the company in regulatory interactions globally.

Responsibilities

• Lead regulatory strategy and oversee IND/CTA/NDA/MAA submission preparation and maintenance for assigned projects
• Author regulatory documents, coordinate health authority meetings, and represent company in regulatory agency interactions
• Develop global regulatory strategies to achieve earliest possible marketing approvals from regulatory authorities
• Provide strategic regulatory guidance to management and cross-functional project teams on development planning and compliance
• Critically review all regulatory submission documentation and oversee dossier filing plans with associated activity timelines

Requirements

• BS/BA in life sciences plus 12+ years pharmaceutical industry experience, or Master's degree plus 10+ years, or PhD plus 7+ years
• Demonstrated success in regulatory submission strategy, execution, and health authority interaction
• Prior US marketing application filing experience preferred; non-US experience strongly preferred
• Experience writing and leading regulatory documents such as meeting requests and briefing books
• Prior managerial experience required
• Detailed knowledge of FDA, EMA, and ICH regulations for IND/CTA/NDA/MAA applications
• Strong written and verbal communication, attention to detail, people management, and negotiation skills