Senior Specialist, Regulatory Strategy
Neurocrine Biosciences
July 02, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
About The Role
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies, including internal audits and inspections. Compiles materials required for submissions, license renewal, and annual registrations. Generates, maintains, monitors, and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trial applications. May act as Regulatory Strategy department contact for internal projects/program activities.
Your Contributions (include, but are not limited to)
- Prepare submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting/maintenance submissions, annual reports, expedited safety reports)
- Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
- Update/maintain logs, databases, and catalogues of regulatory compliance information
- Coordinate review/revision procedures, specifications, and forms
- Compile regulatory filing documents and maintain computerized files
- Serve as Regulatory Strategy contact for internal projects/program activities
- Initiate and maintain program Smartsheet tools for timeline tracking and submission deliverables/program plans
- Ensure quality, consistency, completeness, and accuracy for regulatory submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Perform other job-related duties as assigned
Requirements
- BS/BA degree + 4+ years relevant experience, or Master’s + 2+ years, or JD/PharmD/PhD without experience
- Understand business drivers; strong understanding of processes/procedures/systems and downstream impact
- Proficient with supporting tools/processes; ability to work in a team (may train others)
- Excellent computer skills; strong communications, problem-solving, analytical thinking
- Detail-oriented with ability to see broader departmental picture
- Meet multiple deadlines with high accuracy/efficiency; strong project management skills
- Interpret/apply company standards and regulatory guidance; strong familiarity with regulatory documents
- Strong familiarity with FDA regulations and ICH guidelines; thorough US regulatory drug development knowledge
- Demonstrated knowledge of US FDA and Ex-US ICH drug development guidelines to ensure compliance
Compensation/Benefits (as stated)
- Annual base salary: $103,300.00–$141,000.00; target annual bonus 20% of earned base salary; eligibility for equity long-term incentive
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, health benefits (medical, prescription drug, dental, vision)
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies, including internal audits and inspections. Compiles materials required for submissions, license renewal, and annual registrations. Generates, maintains, monitors, and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trial applications. May act as Regulatory Strategy department contact for internal projects/program activities.
Your Contributions (include, but are not limited to)
- Prepare submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting/maintenance submissions, annual reports, expedited safety reports)
- Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
- Update/maintain logs, databases, and catalogues of regulatory compliance information
- Coordinate review/revision procedures, specifications, and forms
- Compile regulatory filing documents and maintain computerized files
- Serve as Regulatory Strategy contact for internal projects/program activities
- Initiate and maintain program Smartsheet tools for timeline tracking and submission deliverables/program plans
- Ensure quality, consistency, completeness, and accuracy for regulatory submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Perform other job-related duties as assigned
Requirements
- BS/BA degree + 4+ years relevant experience, or Master’s + 2+ years, or JD/PharmD/PhD without experience
- Understand business drivers; strong understanding of processes/procedures/systems and downstream impact
- Proficient with supporting tools/processes; ability to work in a team (may train others)
- Excellent computer skills; strong communications, problem-solving, analytical thinking
- Detail-oriented with ability to see broader departmental picture
- Meet multiple deadlines with high accuracy/efficiency; strong project management skills
- Interpret/apply company standards and regulatory guidance; strong familiarity with regulatory documents
- Strong familiarity with FDA regulations and ICH guidelines; thorough US regulatory drug development knowledge
- Demonstrated knowledge of US FDA and Ex-US ICH drug development guidelines to ensure compliance
Compensation/Benefits (as stated)
- Annual base salary: $103,300.00–$141,000.00; target annual bonus 20% of earned base salary; eligibility for equity long-term incentive
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, health benefits (medical, prescription drug, dental, vision)