Executive Director, Regulatory Strategy

About the role

The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Neurocrine’s Endocrinology pipeline, spanning early development through commercialization.

Responsibilities

• Leads the development and execution of innovative, global regulatory strategies across early- and late-stage Endocrinology programs, including rare and obesity indications
• Integrates scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle management
• Provides guidance on complex regulatory issues to cross-functional teams and senior management, ensuring broad understanding of the benefits and risks of different regulatory strategies
• Serves as a senior regulatory voice in discussions involving safety signals, benefit-risk assessment, and strategic response planning
• Pairs closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies
• Operates as a strategic thought partner to senior leaders, contributing to high-level portfolio and commercial decision-making
• Buys into consensus by presenting compelling, data-driven cases for strategic direction, negotiating persuasively, and addressing disagreements constructively
• Coaches teams in making timely, high-quality decisions that appropriately balance uncertainty with the need for decisive action
• Leads and develops a team of three regulatory strategists, fostering accountability, growth, and high performance
• Demonstrates a consistent record of developing talent through informal mentorship and direct supervisory relationships
• Cultivates a workforce through hiring, promotion, and staff development aligned with current and emerging talent needs
• Champions ethical professional behavior and creates conditions for a productive, respectful, and inclusive work environment
• Ensures compliance with global regulatory requirements across assigned programs
• Guides teams in navigating regulatory ambiguity while maintaining the highest standards of integrity and compliance
• Contributes to broader regulatory leadership initiatives and enterprise governance forums as needed

Requirements

• Typical Experience or Education: BS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience OR Master's degree preferred AND 15+ years of related experience as noted above OR PhD AND 12+ years of related experience
• Common Knowledge & Skills: Proven leadership abilities, including the ability to influence across functions & levels in an organization; skilled diplomat; Demonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively; Successfully manages ambiguity & uncertainty in decision-making; Track record of successfully leveraging relationships with other companies, trade associations, and government-industry coalitions to advance an organization’s interests; Demonstrated record of developing talent through informal mentorship and direct supervisory relationships; Cultivates a workforce through hiring, promotion, and staff development that is well-aligned with current and emerging talent needs; Champions ethical professional behavior; creates conditions for a productive and respectful work environment
• Job Specific Knowledge & Qualifications: Extensive experience developing regulatory strategy across early and commercial stages of development; Experience supporting or maintaining commercial products, with strong understanding of lifecycle management and post-marketing regulatory strategy; Deep understanding of regulatory strategy within rare disease and/or obesity markets strongly preferred; Ability to synthesize scientific, clinical, safety, and business inputs into cohesive regulatory strategy; Experience across diverse therapeutic modalities (e.g., antibodies, peptides, small molecules) is preferred; Strong presentation and communication skills, with the ability to convey complex regulatory strategy to audiences of varying sophistication; Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape

Pay

The annual base salary we reasonably expect to pay is $252,500.00-$344,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans