Director, Regulatory Vault Operations

GSK

21h•Onsite

About The Position

At GSK, we are united by one purpose: to get ahead of disease together. Our Regulatory and Development organisations play a critical role in enabling this mission globally, and we’re now looking for an experienced leader to shape the future of our Regulatory Vault capability. As Director, Regulatory Vault Operations, you will set the strategic direction and lead the delivery of Regulatory Vault Continuous Improvement, Business Systems Ownership (inspection readiness, GxP validation, and service management), and Business Product Management (feature documentation, value frameworks, and backlog prioritization) across GSK’s global regulatory landscape. This is a highly visible leadership role, responsible for ensuring our regulatory systems, data, and insights enable compliant, efficient and forward-looking decision making at scale. You will lead a geographically diverse, multi-disciplinary organisation and work closely with senior stakeholders across Regulatory Affairs, Clinical Development, Tech, Data, and Quality. This role sits at the intersection of regulatory science, data, digital and operations. Your leadership will directly influence how effectively GSK delivers regulatory submissions, uses data to drive insights and ensures compliance across a complex global environment.

Requirements

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 in general, including configuration and customization capabilities, connections with other Vaults (Clinical, Quality, PromoMats in particular), and business process execution specifically for regulatory submissions in a global / large pharmaceutical context.
Strong experience working within the pharmaceutical, biotechnology or life sciences industry, with a focus 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.

Nice To Haves

A doctoral or equivalent advanced qualification (e.g. PhD, PharmD or MD).
Formal training in leadership, project or programme management (e.g. MBA, PMP or similar).
Hands‑on experience with business intelligence and visualisation tools (e.g. Power BI or similar).

Responsibilities

Oversee and optimize the technology infrastructure and digital platforms supporting regulatory and development operations. Ensure systems are reliable, scalable, and aligned with GSK's strategic objectives, facilitating seamless workflows and regulatory compliance.
Partner with Tech and R&D Quality teams to ensure full GxP validation (including GMP), prepare for regular inspections, and maintain zero findings while maintaining a dynamic change and release schedule.
Partner with Regulatory regional support teams, Tech, Veeva, and other R&D support teams to ensure high availability, zero defects, and excellent performance and end user experience in Regulatory Vault.
Develop and execute strategies that integrate system operations, reporting and analytics, and support services to drive continuous improvement and operational excellence within the regulatory and development landscape.
Work closely with cross-functional teams, including IT, data science, regulatory affairs, clinical operations, and quality assurance, to ensure cohesive and coordinated efforts in system operations and support services.
Identify and implement innovative solutions and best practices to enhance system operations, reporting, and support services, leveraging new technologies and methodologies to drive efficiency and effectiveness.
Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards. Proactively manage risks associated with system operations and data integrity.
Lead, mentor, and develop a high-performing team, ensuring they have the skills and resources needed to support GSK’s regulatory and development objectives.

Benefits

annual base salary in Poland for new hires in this position ranges from PLN 381,750 to PLN 636,250 gross
a bonus (if applicable and based on defined, non-discretionary criteria)
awards for exceptional performance (granted at the employer’s discretion)
All statutory benefits will be maintained in accordance with Polish law.
private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave
care of family member leave