Sr. Specialist, Regulatory Strategy
Neurocrine Biosciences · San Diego, CA
RegulatoryFull-time$103k–$141kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
What they're looking for
- Bachelor's degree with 4+ years relevant experience, or Master's with 2+ years, or JD/PharmD/PhD
- Strong familiarity with FDA regulations and ICH guidelines for drug development
- Thorough understanding of US regulatory knowledge and ex-US compliance requirements
- Demonstrated proficiency with regulatory document preparation and submission processes
- Strong project management, analytical, and problem-solving skills
- Excellent computer skills and detail orientation with ability to manage multiple deadlines
- Ability to interpret and apply company standards and regulatory guidance consistently
What you'll be doing
- Prepare and coordinate regulatory submissions including INDs, clinical trial applications, and annual reports
- Conduct reviews and quality checks of clinical regulatory documents and submission materials
- Maintain logs, databases, and compliance tracking systems for regulatory information
- Serve as departmental contact for internal company projects and coordinate with cross-functional teams
- Review investigator packages and authorize drug shipments to clinical sites
Privacy & handoff
This role links to Neurocrine Biosciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.