Sr Manager or Associate Director, Regulatory Operations

Position Summary:

Reporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. The role will work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.

Essential Duties and Responsibilities:

• Support Regulatory Affairs submissions including:
• Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables; proactively track progress, identify risks or dependencies, and drive submission activities to completion.
• May independently lead/coordinate standardized submissions, such as DSURs, IBs, etc.
• Support Regulatory Affairs Department operations, including:
• Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including the timely update of associated trackers.
• Support periodic QC reviews of study TMFs and resolve identified documentation gaps.
• Establish and maintain Regulatory document templates, formatting standards, naming conventions, submission-ready document requirements, and archival practices.
• Maintain organized and inspection-ready Regulatory repositories and archives in accordance with established document management practices.
• Support or lead management of the Regulatory department budget, including forecasts, invoices, and payment approvals.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Education and Experience:

• Undergraduate degree required, advanced degree preferred; RAC certification a plus
• 6+ years of relevant experience in Regulatory Operations or a closely related field; experience in a small or mid-sized company preferred
• Sound knowledge of drug development strategies and regulations
• Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role preferred
• Hands-on experience with regulatory information management or electronic document management systems and with health authority question and commitment tracking
• Strong project management skills, with the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks
• Experience with document formatting and authoring templates, and training colleagues on business processes, RIM or EDMS practices, and submission standards
• Experience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools
• Demonstrated interest and ability to learn new things; develops solutions to technical problems and drives change
• Able to work in an entrepreneurial, fast-paced, dynamic, team-oriented environment
• Strong learning orientation, curiosity, and commitment to science and patients