Set the strategic direction and lead the delivery of Regulatory Vault Continuous Improvement.
Oversee and optimize the technology infrastructure and digital platforms supporting regulatory and development operations.
Partner with Tech and R&D Quality teams to ensure full GxP validation and prepare for regular inspections.
Develop and execute strategies that integrate system operations, reporting and analytics, and support services.
Work closely with cross-functional teams to ensure cohesive efforts in system operations and support services.
Identify and implement innovative solutions and best practices to enhance system operations and reporting.
Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards.
Lead, mentor, and develop a high-performing team to support GSK’s regulatory and development objectives.

An advanced degree in a relevant discipline such as Regulatory Affairs, Pharmaceutical Sciences, Biotechnology, Business or a related field.
Expert level knowledge of Veeva Regulatory Vault and the Vault platform including configuration and customization capabilities.
Strong experience working within the pharmaceutical, biotechnology or life sciences industry, focusing on regulatory affairs, clinical development or regulatory operations.
Strong experience with service management around enterprise systems, including change and release management and end user support.
Strong experience with GxP validation, inspection readiness, and Quality Management Systems including management and resolution of deviations, CAPAs, and findings.
Deep knowledge of regulatory and development systems, including platforms supporting submissions, tracking and regulatory operations (e.g. RIM, eCTD and related environments).
Proven expertise in data, reporting and analytics, using insights to support decision-making and operational performance.
Demonstrated experience leading senior, cross-functional teams and delivering strategic initiatives in complex, matrixed organisations.
A solid understanding of global regulatory requirements and compliance, with the ability to manage risk and ensure data integrity across systems and processes.
Experience operating in global environments, working across multiple regulatory regions and health authorities.

Director, Regulatory Vault Operations

Key skills