Executive Director, Regulatory Strategy
Neurocrine Biosciences
4 hours ago
Remote friendly (San Diego, CA)
United States
$252,500 - $344,000 USD yearly
Corporate Functions
About The Role
- Lead and drive global regulatory strategy across Neurocrine’s Endocrinology pipeline from early development through commercialization.
- Oversee regulatory strategy for programs in rare endocrine disorders and obesity.
- Directly lead a team of three regulatory professionals.
Your Contributions (include, but are not limited to)
Strategic Regulatory Leadership
- Develop and execute innovative, global regulatory strategies across early- and late-stage Endocrinology programs, including rare and obesity indications.
- Integrate scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle management.
- Provide guidance on complex regulatory issues to cross-functional teams and senior management.
- Translate regulatory requirements into differentiated strategy and business opportunity.
- Lead senior-level input on 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 regulatory strategies.
- Serve as a strategic thought partner for high-level portfolio and commercial decision-making.
- Build consensus through data-driven cases, persuasive negotiation, and constructive resolution of disagreements.
- Coach teams to make timely, high-quality decisions balancing uncertainty with decisive action.
People Leadership & Organizational Development
- Lead and develop a team of three regulatory strategists, fostering accountability, growth, and high performance.
- Develop talent through mentorship and direct supervisory relationships.
- Drive workforce development through hiring, promotion, and staff development aligned with emerging talent needs.
- Champion ethical professional behavior and create a productive, respectful, inclusive environment.
Governance & Compliance
- Ensure compliance with global regulatory requirements across assigned programs.
- Guide teams in navigating regulatory ambiguity with integrity and compliance.
Requirements
Typical Experience or Education
- BS/BA in a life science AND BS/BA with 17+ years relevant biopharma and/or regulatory experience (including leadership experience), OR
- Master’s preferred AND 15+ years related experience, OR
- PhD AND 12+ years related experience.
Common Knowledge & Skills
- Proven leadership; ability to influence across functions and levels.
- Ability to build consensus, negotiate persuasively, and address disagreements constructively.
- Ability to manage ambiguity and uncertainty in decision-making.
- Track record leveraging relationships (other companies, trade associations, government-industry coalitions).
- Demonstrated talent development experience (mentorship and direct supervision).
- Strong interpersonal, problem-solving, analytical, and organizational skills; accountability mindset.
- Ensures compliance with regulatory requirements.
Job Specific Knowledge & Qualifications
- Extensive experience developing regulatory strategy across early and commercial stages.
- Experience supporting/maintaining commercial products; strong lifecycle management and post-marketing regulatory strategy.
- Deep understanding of regulatory strategy in 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 (antibodies, peptides, small molecules) (preferred).
- Strong presentation and communication skills.
- Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy.
Benefits (as stated)
- Retirement savings plan (with company match)
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Compensation (as stated)
- Annual base salary: $252,500.00–$344,000.00
- Annual bonus target: 35% of earned base salary
- Eligibility for equity-based long-term incentive program
- Lead and drive global regulatory strategy across Neurocrine’s Endocrinology pipeline from early development through commercialization.
- Oversee regulatory strategy for programs in rare endocrine disorders and obesity.
- Directly lead a team of three regulatory professionals.
Your Contributions (include, but are not limited to)
Strategic Regulatory Leadership
- Develop and execute innovative, global regulatory strategies across early- and late-stage Endocrinology programs, including rare and obesity indications.
- Integrate scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle management.
- Provide guidance on complex regulatory issues to cross-functional teams and senior management.
- Translate regulatory requirements into differentiated strategy and business opportunity.
- Lead senior-level input on 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 regulatory strategies.
- Serve as a strategic thought partner for high-level portfolio and commercial decision-making.
- Build consensus through data-driven cases, persuasive negotiation, and constructive resolution of disagreements.
- Coach teams to make timely, high-quality decisions balancing uncertainty with decisive action.
People Leadership & Organizational Development
- Lead and develop a team of three regulatory strategists, fostering accountability, growth, and high performance.
- Develop talent through mentorship and direct supervisory relationships.
- Drive workforce development through hiring, promotion, and staff development aligned with emerging talent needs.
- Champion ethical professional behavior and create a productive, respectful, inclusive environment.
Governance & Compliance
- Ensure compliance with global regulatory requirements across assigned programs.
- Guide teams in navigating regulatory ambiguity with integrity and compliance.
Requirements
Typical Experience or Education
- BS/BA in a life science AND BS/BA with 17+ years relevant biopharma and/or regulatory experience (including leadership experience), OR
- Master’s preferred AND 15+ years related experience, OR
- PhD AND 12+ years related experience.
Common Knowledge & Skills
- Proven leadership; ability to influence across functions and levels.
- Ability to build consensus, negotiate persuasively, and address disagreements constructively.
- Ability to manage ambiguity and uncertainty in decision-making.
- Track record leveraging relationships (other companies, trade associations, government-industry coalitions).
- Demonstrated talent development experience (mentorship and direct supervision).
- Strong interpersonal, problem-solving, analytical, and organizational skills; accountability mindset.
- Ensures compliance with regulatory requirements.
Job Specific Knowledge & Qualifications
- Extensive experience developing regulatory strategy across early and commercial stages.
- Experience supporting/maintaining commercial products; strong lifecycle management and post-marketing regulatory strategy.
- Deep understanding of regulatory strategy in 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 (antibodies, peptides, small molecules) (preferred).
- Strong presentation and communication skills.
- Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy.
Benefits (as stated)
- Retirement savings plan (with company match)
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Compensation (as stated)
- Annual base salary: $252,500.00–$344,000.00
- Annual bonus target: 35% of earned base salary
- Eligibility for equity-based long-term incentive program