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 and 4+ years relevant experience, or Master's and 2+ years, or advanced degree without experience
- Strong understanding of FDA regulations and ICH guidelines for drug development
- Thorough knowledge of US regulatory requirements and ex-US drug development standards
- Proficiency with regulatory document preparation and quality control systems
- Strong project management, analytical, and problem-solving skills
- Detail-oriented with excellent communication and computer capabilities
- Ability to interpret and apply company standards and regulatory guidance accurately
What you'll be doing
- Prepare and coordinate regulatory submissions including clinical trial applications, INDs, and safety reports
- Conduct quality reviews of clinical regulatory documents and submission packages for compliance
- Maintain and update regulatory tracking databases, logs, and filing systems
- Manage timeline tracking and submission deliverable monitoring using project management tools
- Serve as departmental contact for internal projects and authorize investigator packages and drug shipments
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.