Director, Global Regulatory Strategy

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Neurocrine Biosciences, Inc. seeks a senior regulatory leader to direct regulatory activities for development products from preclinical stages through life-cycle management, ensuring alignment with local and regional requirements and with company policies.

You will develop global regulatory strategies, lead IND/CTA/NDA/MAA submissions, and mentor teams while interacting with health authorities to secure timely approvals across markets.

Qualifications

• BS/BA degree in life sciences and 12+ years of pharma industry experience with regulatory submissions.
• Master's degree in life sciences and 10+ years of related experience.
• PhD in life sciences with 7+ years of related experience.
• Previous managerial experience is required.
• Recognized as an internal thought leader with extensive technical and business expertise.

Responsibilities

• Provide regulatory leadership for one or more development projects, including strategy and submission maintenance.
• Author and prepare submission documents and briefing materials; coordinate for health authority meetings.
• Develop regulatory strategies to enable earliest marketing approvals by global authorities.
• Advise management and project teams on regulatory issues for IND/CTA and NDA/MAA planning and submission.
• Serve as the regulatory health authority contact and liaison with regulators during all stages of development and commercialization.
• Oversee dossier filing plans and regulatory timelines.
• Integrate global regulatory responsibilities into development strategy and submissions.
• Critically review documentation to ensure compliance with data standards and requirements.

Skills

Regulatory leadership

Regulatory strategy

Health authority interaction

Project management

Strategic liaison

Documentation authoring

Communication skills

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in life sciences

Job description

Neurocrine Biosciences, Inc. seeks a senior regulatory leader to direct regulatory activities for development products from preclinical stages through life-cycle management, ensuring alignment with local and regional requirements and with company policies.

You will develop global regulatory strategies, lead IND/CTA/NDA/MAA submissions, and mentor teams while interacting with health authorities to secure timely approvals across markets.