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.
The Role
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.
Key Responsibilities
System Operations: 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.
GxP Validation and Inspection Readiness: 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.
Service Management: 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.
Strategic Leadership: 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.
Cross-functional Collaboration: 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.
Innovation and Continuous Improvement: 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.
Compliance and Risk Management: Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards. Proactively manage risks associated with system operations and data integrity.
Team Leadership and Development: Lead, mentor, and develop a high-performing team, ensuring they have the skills and resources needed to support GSK’s regulatory and development objectives.
Why This Role Is Important
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.
Basic Qualifications and Skills
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.
Preferred Qualifications
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).
Closing Date for Applications – 28 April 2026
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ for your online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your cover letter and CV will be used to assess your application.
The annual base salary in Poland for new hires in this position ranges from PLN 381,750 to PLN 636,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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