Director of Regulatory Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory Operations based in the United States.

• Lead global regulatory operations, overseeing electronic and paper submissions, publishing activities, archiving, regulatory information management, and related systems.
• Develop, implement, and maintain submission strategies aligned with broader global regulatory objectives and product portfolio needs.
• Coordinate cross-functional submission planning, ensuring regulatory documents are delivered accurately, consistently, and within established timelines.
• Establish and maintain compliant GxP electronic systems and paper-based processes.
• Lead the selection, implementation, validation, maintenance, and lifecycle management of regulatory submission software and technology platforms.
• Partner with Information Technology and other stakeholders to optimize regulatory systems.
• Monitor regulatory trends, emerging technologies, and changes to international guidance, assess impact, and develop action plans.
• Oversee external vendors and service providers, including resource planning, contracting, performance coordination, budget forecasting, and expenditure management.
• Support compliance activities and inspection readiness.
• Maintain submission standards, templates, formatting guidelines, glossaries, and procedures.
• Develop and maintain SOPs, performance indicators, and analytics.
• Coordinate regulatory disclosure, transparency, and data-sharing activities.
• Collaborate with multidisciplinary teams to forecast submission needs and allocate resources.

• Bachelor's degree in life sciences or related discipline with at least 12 years of regulatory experience, or a master's degree with at least 10 years of regulatory experience.
• At least 6 years of experience in a regulatory operations leadership role.
• Strong working knowledge of global regulatory submission requirements, including eCTD, NeeS, and paper-based submissions.
• Experience managing regulatory submission publishing tools, document templates, formatting processes, and electronic submission workflows.
• Familiarity with Veeva Vault for Submissions or comparable systems; experience with ISI Toolbox is valuable.
• Knowledge of applicable U.S. and international regulations, guidelines, and health authority requirements.
• Demonstrated ability to lead cross-functional initiatives, manage external vendors, and coordinate multiple projects.
• Experience with regulatory systems implementation, validation, maintenance, and software lifecycle management.
• Strong project planning, organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.

• Annual salary: estimated range of $265,000–$295,000 USD.
• Eligibility to participate in performance-based bonus programs.
• Access to stock-based compensation programs.
• Competitive benefits package.
• Remote opportunities available within the continental United States, with Hayward or Brisbane, California, preferred for candidates able to work on-site.