Senior Regulatory Affairs Specialist

Job Description

Sr. Specialist, Regulatory Strategy | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, located in San Diego. Neurocrine Biosciences is a biopharmaceutical company dedicated to relieving suffering by discovering, developing, and commercializing life-changing treatments for neurological, psychiatric, endocrine, and immunological disorders. This role is essential for coordinating and preparing regulatory submissions, ensuring that new and mature products align with local and regional registration requirements, company policies, and support the timely approval of vital medicines for patients.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person San Diego
• Pay: $103300–$141000 yearly
• Mission: This person coordinates and prepares document packages for regulatory submissions to ensure compliance and support the earliest possible approvals of clinical trials and new products.
• Tech Stack: Smartsheet tools

What You’ll Actually Do
• Submissions: Prepare documents for regulatory authorities, including clinical trial applications, IND/IND supporting documents, and maintenance submissions.
• Document Review: Conduct reviews of clinical regulatory documents and perform quality checks on submission documentation and publishing output.
• Information Management: Update and maintain logs, databases, and catalogues of regulatory compliance information.
• Process Coordination: Coordinate the review and revision of regulatory procedures, specifications, and forms.
• Project Tracking: Initiate and maintain program Smartsheet tools for timeline tracking, submission deliverable tracking, and program plans.

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 experience. This position is for a Senior-level role in Regulatory Strategy.
• Experience: 4+ years of experience involving the preparation and coordination of regulatory submissions, with strong familiarity with FDA regulations and ICH guidelines.
• Skills: Strong communications, problem-solving, analytical thinking, project management skills, and meticulous attention to detail.
• Skills: Thorough understanding of US FDA and Ex-US ICH drug development regulatory guidelines, ensuring compliance with local and regional requirements.