Overview
The Head of Regulatory Data Management & Support leads global regulatory data governance, ensuring compliance with xEVMPD, PMS, IDMP standards, manages critical documents (CPPs, correspondence, legalizations), and drives continuous improvement of data quality and digital tools across the product lifecycle.
Key Responsibilities
- Establish, maintain, and enforce governance frameworks for regulatory master data, metadata, controlled vocabularies, transactional data, and data standards in line with global best practices.
- Ensure global compliance with xEVMPD, PMS, IDMP/SPOR, and other structured data requirements; lead data quality programs (validation, reconciliation, audit readiness).
- Oversee end‑to‑end management of xEVMPD submissions, PMS data capture, maintenance, and reporting, and partner with pharmacovigilance, CMC, and regulatory affairs to maintain consistent product data across systems.
- Lead the global process for capturing, tracking, and archiving Health Authority correspondence, ensuring audit‑ready records and metadata linkage.
- Manage the global process for requesting, tracking, and delivering Certificates of Pharmaceutical Product (CPPs) and related documents, establishing relationships with manufacturing sites and vendors; implement digital tools to streamline workflow.
- Build and lead a global team responsible for regulatory data operations, RIMS support, CPP/document management, and Health Authority correspondence.
- Represent regulatory data and support functions in global governance forums and digital transformation initiatives; provide expert guidance on data impacts for new products, lifecycle changes, and market expansions.
- Foster a culture of data quality, operational excellence, and continuous improvement; drive automation and digital transformation of regulatory reporting processes.
Qualifications
- Degree or equivalent experience.
- Fluent in English (oral & written).
- 20+ years of experience in regulatory operations, preferably in the generic field.
- Expert knowledge of regulatory affairs, end‑to‑end regulatory processes, and data flows.
- Deep understanding of global and regional regulatory data models (ISO IDMP, SPOR, xEVMPD).
- Detailed operating knowledge of the Veeva ecosystem and cross‑functional data dependencies.
- Experience translating regulatory requirements into scalable processes; strong methodology for risk management, digital enablement, and high‑volume transactional automation.
Benefits (United Kingdom)
Competitive salary, annual bonus, pension scheme, health insurance, 24 days annual leave, flexible working arrangements, employee recognition scheme, and learning & development opportunities.
Location
United Kingdom
Commitment to Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Head of Regulatory Data Management and Support in Newtown employer: Sandoz Limited
As the Head of Regulatory Data Management and Support, you will join a forward-thinking company that prioritises data quality and operational excellence. With a strong commitment to employee growth, we offer competitive salaries, flexible working arrangements, and a culture that fosters continuous improvement and innovation. Located in the UK, our supportive environment encourages collaboration across global teams, ensuring you have the resources and recognition needed to thrive in your role.
