Hiring: Sr. Specialist, Regulatory Strategy Company: Neurocrine Biosciences Location: San Diego, CA Job Posted Time: 2026-09-10 11:48:37 Target Skills & Keywords : Project Management, Regulatory Compliance About the job Experience: •BS/BA degree AND 4+ years of relevant experience, or OR Master’s AND 2+ years of related experience, or OR JD or PharmD or PhD AND without experience •4+ years of relevant experience, or OR Master’s AND 2+ years of related experience, or OR JD or PharmD or PhD AND without experience Required Skills: •Your Contributions (include, But Are Not Limited To) •Performs the preparation of submissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports) •Conducts reviews of clinical regulatory documents. Performs quality checks of submission documentation and publishing output •Updates and maintains logs, databases and catalogues of regulatory compliance information •Coordinates the review and revision procedures, specifications, and forms. •Compiles regulatory filing documents and maintain computerized files to support all documentation systems •Serves as Regulatory Strategy department contact for internal company projects or program activities •Lead and oversee initiating and maintaining program Smartsheet tools for timeline tracking, submission deliverable tracking and program plans as assigned. Qualifications: •Understands key business drivers and uses this understanding to accomplish work •Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas •Proficient with tools and processes that support work conducted by functional area •Demonstrated capacity to work as part of a team; may train lower levels Compensation: •$103,300 - $141,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!