Senior Specialist, Regulatory Strategy
Neurocrine Biosciences
17 days ago
Remote friendly (San Diego, CA)
United States
Corporate Functions
About the Role
Performs coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local/regional registration requirements and company policies; compiles submission materials; maintains tracking/control systems and timelines; stays current on regulatory procedures/changes; recommends strategies for earliest possible clinical trial application approvals; may serve as Regulatory Strategy contact for internal projects.
Your Contributions (include, but are not limited to)
- Prepare regulatory submissions (e.g., clinical trial applications, IND/IND supporting and maintenance submissions, annual reports, expedited safety reports)
- Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
- Maintain logs/databases/catalogues of regulatory compliance information
- Coordinate review/revision of procedures, specifications, and forms
- Compile regulatory filing documents; maintain computerized files to support documentation systems
- Serve as Regulatory Strategy contact for internal projects/program activities
- Initiate/maintain Smartsheet tools for timeline and deliverable tracking and program plans
- Ensure quality, consistency, completeness, and accuracy of submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Perform other assigned duties
Requirements
- BS/BA with 4+ years relevant experience, OR Master’s with 2+ years, OR JD/PharmD/PhD
- Knowledge of FDA and ICH guidelines; strong understanding of drug development laws/regulations/standards
- Strong regulatory document familiarity; excellent computer skills; strong communications, problem-solving, analytical thinking, and project management
- Detail-oriented with ability to meet multiple deadlines with high accuracy/efficiency
Compensation/Benefits
- Annual base salary: $103,300–$141,000; annual bonus target 20%; equity long-term incentive eligibility; retirement plan match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Performs coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local/regional registration requirements and company policies; compiles submission materials; maintains tracking/control systems and timelines; stays current on regulatory procedures/changes; recommends strategies for earliest possible clinical trial application approvals; may serve as Regulatory Strategy contact for internal projects.
Your Contributions (include, but are not limited to)
- Prepare regulatory submissions (e.g., clinical trial applications, IND/IND supporting and maintenance submissions, annual reports, expedited safety reports)
- Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
- Maintain logs/databases/catalogues of regulatory compliance information
- Coordinate review/revision of procedures, specifications, and forms
- Compile regulatory filing documents; maintain computerized files to support documentation systems
- Serve as Regulatory Strategy contact for internal projects/program activities
- Initiate/maintain Smartsheet tools for timeline and deliverable tracking and program plans
- Ensure quality, consistency, completeness, and accuracy of submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Perform other assigned duties
Requirements
- BS/BA with 4+ years relevant experience, OR Master’s with 2+ years, OR JD/PharmD/PhD
- Knowledge of FDA and ICH guidelines; strong understanding of drug development laws/regulations/standards
- Strong regulatory document familiarity; excellent computer skills; strong communications, problem-solving, analytical thinking, and project management
- Detail-oriented with ability to meet multiple deadlines with high accuracy/efficiency
Compensation/Benefits
- Annual base salary: $103,300–$141,000; annual bonus target 20%; equity long-term incentive eligibility; retirement plan match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.