Regulatory Strategy Lead — Submissions & Compliance

Neurocrine Biosciences; San Diego (CA); On-site; USD 103,000 - 141,000; Full time

Benefits offered by this job

Retirement plan with company match

Paid vacation

Medical leave

Health benefits package

Job summary

Neurocrine Biosciences seeks a Regulatory Submissions Coordinator to prepare and coordinate document packages for regulatory submissions, renewals and annual registrations. You will maintain tracking systems, monitor timelines, and ensure compliance with FDA, ICH, and local requirements across programs.

Responsibilities include reviewing regulatory documents, updating logs, and serving as a department contact for internal projects. A BS/BA with 4+ years or a Master’s with 2+ years is preferred.

Qualifications

• BS/BA degree with 4+ years of relevant experience, or Master’s with 2+ years, or JD/PharmD/PhD with no experience.
• Strong understanding of FDA regulations and ICH guidelines for regulatory submissions.
• Proficient with tools and processes that support regulatory work; ability to manage multiple deadlines.

Responsibilities

• Prepares regulatory submissions to authorities (clinical trial applications, INDs, annual reports, safety reports).
• Reviews clinical regulatory documents and performs quality checks on submission documentation.
• Updates and maintains logs, databases and catalogues of regulatory information.
• Coordinates review and revision procedures, specifications and forms.
• Compiles filing documents and maintains computerized files to support documentation systems.

Skills

Strong communications

Problem solving

Analytical thinking

Project management

Team collaboration

Detail oriented

Education

BS/BA degree

Master’s degree

JD/PharmD/PhD

Tools

Smartsheet

MS Office

Job description

Neurocrine Biosciences seeks a Regulatory Submissions Coordinator to prepare and coordinate document packages for regulatory submissions, renewals and annual registrations. You will maintain tracking systems, monitor timelines, and ensure compliance with FDA, ICH, and local requirements across programs.

Responsibilities include reviewing regulatory documents, updating logs, and serving as a department contact for internal projects. A BS/BA with 4+ years or a Master’s with 2+ years is preferred.