Executive Director, Regulatory Strategy
Neurocrine Biosciences
June 26, 2026
Remote friendly (San Diego, CA)
United States
$252,500 - $344,000 USD yearly
Corporate Functions
About The Role
- The Executive Director, Regulatory Strategy – Endocrinology is responsible for shaping and driving global regulatory strategy across the Endocrinology pipeline (early development through commercialization), overseeing regulatory strategy for rare endocrine disorders and obesity, and leading a team of three regulatory professionals.
Your Contributions
Strategic Regulatory Leadership
- Lead development and execution of global regulatory strategies across early- and late-stage Endocrinology programs (rare and obesity indications)
- Integrate scientific, clinical, safety, and commercial inputs to build regulatory roadmaps from first-in-human through post-marketing lifecycle management
- Provide guidance on complex regulatory issues to cross-functional teams and senior management
- Advise on translating regulatory requirements into differentiated strategy and business opportunity
- Serve as a senior regulatory voice for safety signals, benefit-risk assessment, and strategic response planning
Cross-Functional Influence & Commercial Value Creation
- Partner with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned, value-generating strategies
- Operate as a strategic thought partner to senior leaders on portfolio and commercial decisions
- Build consensus with data-driven cases, persuasive negotiation, and constructive issue resolution
- Coach teams to make timely, high-quality decisions balancing uncertainty with action
People Leadership & Governance & Compliance
- Lead and develop a team; hire, promote, and develop staff; foster accountability and inclusion
- Ensure compliance with global regulatory requirements and maintain integrity standards
Requirements
- BS/BA in life science AND BS/BA; 17+ years relevant biopharma/regulatory experience (with prior leadership) OR Master’s preferred; 15+ years OR PhD; 12+ years
- Extensive regulatory strategy experience across early and commercial stages
- Experience supporting/maintaining commercial products; lifecycle management and post-marketing strategy
- Strong presentation/communication; FDA regulatory frameworks and evolving policy landscape
- Rare disease and/or obesity regulatory strategy experience strongly preferred; diverse modalities experience preferred (e.g., antibodies, peptides, small molecules)
Benefits
- Annual bonus target: 35% of earned base salary; eligibility for equity-based long-term incentive
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision)
Compensation
- Annual base salary: $252,500.00–$344,000.00
Application Instructions
- Apply for the position.
- The Executive Director, Regulatory Strategy – Endocrinology is responsible for shaping and driving global regulatory strategy across the Endocrinology pipeline (early development through commercialization), overseeing regulatory strategy for rare endocrine disorders and obesity, and leading a team of three regulatory professionals.
Your Contributions
Strategic Regulatory Leadership
- Lead development and execution of global regulatory strategies across early- and late-stage Endocrinology programs (rare and obesity indications)
- Integrate scientific, clinical, safety, and commercial inputs to build regulatory roadmaps from first-in-human through post-marketing lifecycle management
- Provide guidance on complex regulatory issues to cross-functional teams and senior management
- Advise on translating regulatory requirements into differentiated strategy and business opportunity
- Serve as a senior regulatory voice for safety signals, benefit-risk assessment, and strategic response planning
Cross-Functional Influence & Commercial Value Creation
- Partner with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned, value-generating strategies
- Operate as a strategic thought partner to senior leaders on portfolio and commercial decisions
- Build consensus with data-driven cases, persuasive negotiation, and constructive issue resolution
- Coach teams to make timely, high-quality decisions balancing uncertainty with action
People Leadership & Governance & Compliance
- Lead and develop a team; hire, promote, and develop staff; foster accountability and inclusion
- Ensure compliance with global regulatory requirements and maintain integrity standards
Requirements
- BS/BA in life science AND BS/BA; 17+ years relevant biopharma/regulatory experience (with prior leadership) OR Master’s preferred; 15+ years OR PhD; 12+ years
- Extensive regulatory strategy experience across early and commercial stages
- Experience supporting/maintaining commercial products; lifecycle management and post-marketing strategy
- Strong presentation/communication; FDA regulatory frameworks and evolving policy landscape
- Rare disease and/or obesity regulatory strategy experience strongly preferred; diverse modalities experience preferred (e.g., antibodies, peptides, small molecules)
Benefits
- Annual bonus target: 35% of earned base salary; eligibility for equity-based long-term incentive
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision)
Compensation
- Annual base salary: $252,500.00–$344,000.00
Application Instructions
- Apply for the position.