Sr. Specialist, Regulatory Strategy

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.

• 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

• 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