Regulatory Strategy Specialist — Submissions & Approvals

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 and holidays

Medical, dental & vision coverage

Paid caregiver/parental leave

Job summary

Neurocrine Biosciences is seeking a regulatory submissions coordinator to prepare and manage regulatory filings for clinical trials and product registrations. You will ensure compliance with FDA/ICH guidelines, reviews, and maintains documentation across submission lifecycle.

The role requires a BS/BA with 4+ years of regulatory experience or a Master’s with 2+ years, and familiarity with Smartsheet and regulatory databases. Team collaboration and strong communication are essential.

Qualifications

• BS/BA with 4+ years regulatory experience, or Master’s with 2+ years, or JD/PharmD/PhD with no experience.
• Understands business drivers and downstream impact on work.
• Proficient with tools and processes in regulatory work.
• Ability to work as part of a team and potentially train lower levels.
• Strong familiarity with FDA regulations and ICH guidelines for submissions.

Responsibilities

• Prepare regulatory submissions to authorities (clinical trial applications, INDs and annual reports).
• Review clinical regulatory documents and perform quality checks on submissions.
• Maintain logs, databases and catalogs of regulatory information.
• Coordinate review and revision procedures, specs and forms.
• Serve as Regulatory Strategy contact for internal projects; manage Smartsheet timelines.

Skills

Regulatory submissions coordination

Regulatory strategy collaboration

Project management

Strong communication

Attention to detail

Education

BS/BA + 4+ years experience

Master’s + 2+ years

JD/PharmD/PhD + applicable experience

Tools

Smartsheet

Regulatory databases

Microsoft Office

Job description

Neurocrine Biosciences is seeking a regulatory submissions coordinator to prepare and manage regulatory filings for clinical trials and product registrations. You will ensure compliance with FDA/ICH guidelines, reviews, and maintains documentation across submission lifecycle.

The role requires a BS/BA with 4+ years of regulatory experience or a Master’s with 2+ years, and familiarity with Smartsheet and regulatory databases. Team collaboration and strong communication are essential.