Regulatory Strategy, Specialist/Sr. Specialist – Regulatory Submissions Coordination

Job Description

Sr. Specialist, Regulatory Strategy | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, likely located in San Diego, CA. The company is dedicated to discovering, developing, and commercializing life-changing treatments for patients suffering from neurological, psychiatric, endocrine, and immunological disorders. This role is crucial for ensuring that new and existing products meet all local and regional regulatory requirements, allowing the company to bring its vital medicines to patients efficiently and compliantly. Your work directly contributes to relieving suffering by facilitating the approval and maintenance of essential therapies.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person – USA (California), USA – San Diego
• Pay: $103300–$141000 yearly
• Team: Regulatory Strategy department
• Mission: Coordinate and prepare regulatory document packages to ensure compliance and timely approval of treatments.
• Tech Stack: Smartsheet

What You’ll Actually Do
• Submissions: Prepare clinical trial applications, IND/IND supporting documents, maintenance submissions, annual reports, and expedited safety reports for regulatory authorities.
• Document Review: Conduct thorough reviews of clinical regulatory documents and perform quality checks on submission documentation and publishing outputs.
• Information Management: Update and maintain logs, databases, and catalogues of regulatory compliance information, ensuring data accuracy and accessibility.
• Project Coordination: Serve as the primary Regulatory Strategy department contact for various internal company projects or program activities.
• Tracking & Planning: Initiate and maintain program Smartsheet tools for timeline tracking, submission deliverable tracking, and overall program plans as assigned.

The Must-Haves
• Background: Bachelor’s degree with 4+ years of relevant experience, or a Master’s degree with 2+ years of related experience, or a JD, PharmD, or PhD without prior experience.
• Experience: 4+ years of relevant experience in regulatory affairs, demonstrating strong familiarity with FDA regulations and ICH guidelines for regulatory submissions. Proven knowledge of US FDA and Ex-US ICH drug development regulatory guidelines is essential.
• Skills: Strong communication, problem-solving, and analytical thinking skills. Excellent computer proficiency, strong project management capabilities, and a detail-oriented approach with the ability to understand broader departmental implications. Must be adept at meeting multiple deadlines with high accuracy.