Senior Specialist, Regulatory Strategy

Neurocrine Biosciences • San Diego, CA

6d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline. The Senior Specialist, Regulatory Strategy role performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements, company policies, internal audits, and inspections. This role compiles all materials required for submissions, license renewals, and annual registrations, generates, maintains, monitors, and improves tracking/control systems, and stays informed of regulatory procedures and changes. The position also maintains and tracks timelines for regulatory deliverables and recommends strategies for the earliest possible approvals of clinical trials applications. The role may act as the Regulatory Strategy department contact for various internal projects or program activities.

Requirements

• BS/BA degree AND 4+ years of relevant experience, OR Master’s AND 2+ years of related experience, OR JD or PharmD or PhD AND without experience.
• Understands key business drivers and uses this understanding to accomplish work.
• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas.
• Proficient with tools and processes that support work conducted by functional area.
• Ability to work as part of a team; may train lower levels.
• Excellent computer skills.
• Strong communications, problem-solving, analytical thinking skills.
• Detail oriented yet can see broader picture for department.
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency.
• Strong project management skills.
• Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed.
• Strong familiarity with regulatory documents.
• Strong familiarity with FDA regulations and ICH guidelines for regulatory submissions.
• Thorough understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge).
• Demonstrated knowledge of US FDA and Ex-US ICH drug development regulatory guidelines to ensure compliance with local and regional requirements, as well as with company policies.

Responsibilities

• Performs the preparation of submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports)
• Conducts reviews of clinical regulatory documents.
• Performs quality checks of submission documentation and publishing output.
• Updates and maintains logs, databases, and catalogues of regulatory compliance information.
• Coordinates the review and revision procedures, specifications, and forms.
• Compiles regulatory filing documents and maintains computerized files to support all documentation systems.
• Serves as Regulatory Strategy department contact for internal company projects or program activities.
• Responsible for initiating and maintaining program Smartsheet tools for timeline tracking, submission deliverable tracking, and program plans as assigned.
• Ensures quality, consistency, completeness, and accuracy for all regulatory submissions.
• Review investigator packages and authorize drug shipments to clinical sites.
• Performs other job related duties as assigned.

Benefits

• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior