Sr. Specialist, Regulatory Strategy

Scorpion Therapeutics; San Diego (CA); On-site; USD 95,000 - 160,000; Full time

Job summary

Scorpion Therapeutics in San Diego, CA is seeking a Regulatory Submissions Specialist to coordinate and prepare document packages for regulatory submissions for new and mature products, ensuring alignment with US FDA requirements and ICH guidelines. You will compile materials for submissions, license renewals, and annual registrations, maintain tracking systems, and support internal audits and inspections.

The role emphasizes meticulous timelines, cross-functional collaboration, and adherence to

Qualifications

• BS/BA with 4+ years relevant experience, or MS with 2+ years, or JD/PharmD/PhD with no experience.
• Strong understanding of regulatory documents, FDA regulations, and ICH guidelines.
• Thorough understanding of laws/standards/guidance governing drug development (US regulatory knowledge)
• Demonstrated knowledge of US FDA and Ex-US ICH guidelines
• Excellent computer skills; strong communications, problem-solving, analytical, and project management skills
• Detail oriented; ability to meet multiple deadlines with accuracy and efficiency; ability to interpret/apply company standards and regulatory guidance

Responsibilities

• Prepare submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting documents, maintenance submissions, annual reports, expedited safety reports)
• Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
• Update and maintain logs, databases, and catalogues of regulatory compliance information
• Coordinate review/revision procedures, specifications, and forms
• Compile regulatory filing documents and maintain computerized files
• Serve as Regulatory Strategy contact for internal projects/program activities
• Initiate and maintain Smartsheet tools for timeline/submission deliverables tracking and program plans
• Ensure quality, consistency, completeness, and accuracy of submissions
• Review investigator packages and authorize drug shipments to clinical sites
• Perform other assigned duties

Skills

Regulatory knowledge

Project management

Attention to detail

Communication

Analytical thinking

Education

Bachelor's degree in a related field

Master’s degree or professional doctorate

Tools

Smartsheet

Job description

About the 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 and company policies, including internal audits and inspections. Compiles materials for submissions, license renewal, and annual registrations. Generates, maintains, monitors, and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trial applications. May act as Regulatory Strategy department contact for internal projects.

Your Contributions (include, but are not limited to)

• Prepare submissions to regulatory authorities (e.g., clinical trial applications, IND/IND supporting documents, maintenance submissions, annual reports, expedited safety reports)
• Review clinical regulatory documents; perform quality checks of submission documentation and publishing output
• Update and maintain logs, databases, and catalogues of regulatory compliance information
• Coordinate review/revision procedures, specifications, and forms
• Compile regulatory filing documents and maintain computerized files
• Serve as Regulatory Strategy contact for internal projects/program activities
• Initiate and maintain Smartsheet tools for timeline/submission deliverables tracking and program plans
• Ensure quality, consistency, completeness, and accuracy of submissions
• Review investigator packages and authorize drug shipments to clinical sites
• Perform other assigned duties

Requirements

• BS/BA + 4+ years relevant experience, or Master’s + 2+ years, or JD/PharmD/PhD with no experience
• Strong understanding of regulatory documents, FDA regulations, and ICH guidelines
• Thorough understanding of laws/standards/guidance governing drug development (US regulatory knowledge)
• Demonstrated knowledge of US FDA and Ex-US ICH guidelines
• Excellent computer skills; strong communications, problem-solving, analytical, and project management skills
• Detail oriented; ability to meet multiple deadlines with accuracy and efficiency; ability to interpret/apply company standards and regulatory guidance