Regulatory Affairs Specialist – Regulatory Submissions

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. Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. This role is crucial for coordinating and preparing regulatory submissions for new and existing products, ensuring compliance with global regulatory requirements and company policies. The Sr. Specialist plays a key part in facilitating the earliest possible approvals for clinical trials and maintaining regulatory compliance across the company’s diverse portfolio.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person, San Diego, CA
• Pay: $103300–$141000 yearly
• Mission: This person coordinates and prepares regulatory document packages to ensure compliance, maintain registrations, and facilitate timely approvals for new and mature products.
• Tech Stack: Smartsheet

What You’ll Actually Do
• Prepare and coordinate document packages for regulatory submissions for new and mature products, including clinical trial applications and IND/IND supporting documents.
• Compile all necessary materials for submissions, license renewals, annual registrations, and expedited safety reports.
• Recommend strategies to achieve the earliest possible approvals for clinical trial applications and submissions.
• Serve as the primary Regulatory Strategy department contact for various internal company projects or program activities.
• Initiate and maintain program Smartsheet tools for timeline tracking, submission deliverable tracking, and overall program plans.

The Must-Haves
• Background: Bachelor’s degree in a relevant scientific or technical field, coupled with a strong understanding of regulatory strategy.
• Experience: At least 4 years of relevant experience in regulatory affairs, with demonstrated knowledge of US FDA regulations and ICH guidelines for drug development and submissions.
• Skills: Strong communication, problem-solving, and analytical thinking skills; detail-oriented with strong project management capabilities; thorough understanding of US regulatory knowledge, laws, regulations, standards, and guidance governing drug development; proficiency with tools and processes supporting regulatory functions, including Smartsheet.