Senior Director, Regulatory Operations

Job description

**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.** This senior leadership role offers the opportunity to shape and oversee global regulatory operations within an innovative, fast-paced life sciences environment. You will lead regulatory submission strategy, publishing, information management, and systems to support product development and regulatory compliance worldwide. Working closely with cross-functional teams, you will ensure submissions meet the highest standards of quality, accuracy, and timeliness. You will also drive the implementation and optimization of regulatory technology platforms, compliant processes, and document management practices. By monitoring evolving regulations and emerging technologies, you will help the organization anticipate change and maintain global regulatory readiness. This role is ideal for an experienced regulatory operations leader who combines strategic thinking, technical expertise, and a commitment to continuous improvement. ### Accountabilities - 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 that meet applicable regulatory requirements, guidelines, and internal standards. - 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 and enable efficient, reliable global submission workflows. - Monitor regulatory trends, emerging technologies, and changes to international guidance, assess their potential impact, and develop appropriate 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 by ensuring regulatory operations processes, documentation, and systems are appropriately maintained. - Maintain submission standards, templates, formatting guidelines, glossaries, and procedures to promote consistency and high-quality regulatory documentation. - Develop and maintain standard operating procedures (SOPs), performance indicators, and analytics to improve operational efficiency and support strategic decision-making. - Coordinate regulatory disclosure, transparency, and data-sharing activities where applicable, ensuring appropriate handling of information submitted to authorities and made available to the public. - Collaborate with multidisciplinary teams to forecast submission needs, allocate resources effectively, and support the successful execution of major global regulatory milestones. ## Requirements - Bachelor's degree in life sciences or a related discipline with at least 12 years of regulatory experience, or a master's degree in a related field with at least 10 years of regulatory experience. - At least 6 years of experience in a regulatory operations leadership role, including team leadership and the management of complex operational responsibilities. - Strong working knowledge of global regulatory submission requirements, including electronic Common Technical Document (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 regulatory information and document management systems; experience with ISI Toolbox is also 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 simultaneously. - Experience with regulatory systems implementation, validation, maintenance, and software lifecycle management. - Strong project planning, organizational, analytical, and problem-solving skills, with exceptional attention to detail. - Excellent written and verbal communication skills and the ability to build effective working relationships across multidisciplinary teams. - Ability to work independently with moderate supervision, exercise sound judgment, and manage competing priorities in a dynamic environment. - A proactive, adaptable, and collaborative approach, with a commitment to integrity, continuous improvement, and data-driven decision-making. ## Benefits - Annual salary: Estimated range of $265,000–$295,000 USD, depending on qualifications, experience, skills, and other relevant factors. - Performance incentives: Eligibility to participate in performance-based bonus programs. - Equity opportunities: Access to stock-based compensation programs. - Comprehensive benefits: A competitive benefits package designed to support employee well-being and financial security. - Work flexibility: Remote opportunities available within the continental United States, with Hayward or Brisbane, California, preferred for candidates able to work on-site. - Leadership impact: The opportunity to influence global regulatory operations strategy, technology, and compliance across a product portfolio. - Collaborative environment: Work with multidisciplinary teams in an innovative, science-driven setting focused on operational excellence. - Professional growth: Opportunities to advance regulatory capabilities, optimize systems and processes, and contribute to continuous organizational improvement.