Regulatory Operations Manager

Job Summary

Leading regulatory operations across the portfolio, the full-time Sr Manager/Associate Director, Regulatory Operations will build and manage the Regulatory Information Management System, oversee submission planning and execution, and establish efficient processes for regulatory records and document management, with the option to work remotely or in hybrid settings in San Diego or South San Francisco.

Key responsibilities

• Support Regulatory Affairs submissions by defining content, responsibilities, timelines, and deliverables while tracking progress and driving activities to completion
• Maintain accurate regulatory submission records and ensure timely updates of associated trackers, while supporting periodic QC reviews of study TMFs
• Manage the Regulatory department budget, including forecasts, invoices, and payment approvals, while ensuring compliance with document management practices

Required qualifications

• Undergraduate degree required; advanced degree preferred, with RAC certification a plus
• 6+ years of relevant experience in Regulatory Operations or a closely related field, preferably in a small or mid-sized company
• Sound knowledge of drug development strategies and regulations, with experience in preparing marketing applications preferred
• Hands-on experience with regulatory information management or electronic document management systems
• Strong project management skills with the ability to manage multiple priorities and operational risks