Head of Regulatory Data Management and Support in Cambridge

At Sandoz, our Purpose is pioneering access for patients. The Head of Regulatory Data Management & Support must combine deep regulatory knowledge with strong data governance leadership and operational execution experience, with an emphasis on xEVMPD / PMS data compliance, Health Authority correspondence management processes, CPP management, and other critical regulatory document workflows. This leader is a key contributor to the global strategy, governance, and operational execution of all regulatory data and critical regulatory support processes across the product lifecycle. The role ensures that product, submission, safety, and lifecycle data—spanning xEVMPD, PMS, IDMP‑aligned datasets, RIMS content, and Health Authority correspondence—is accurate, compliant, submitted on time, managed in accordance with required legislation, and readily accessible.

Responsibilities

• Regulatory Data Governance and Quality: Design and build a best‑in‑class data management operations team focused on delivering timely regulatory data updates to maintain a continuous state of compliance with regional and global guidance and legislation. Establish and maintain governance frameworks for regulatory master data, metadata, controlled vocabularies, transactional regulatory data and data standards aligned with best practice and global data standards. Ensure global compliance with xEVMPD, PMS, IDMP/SPOR, and other structured data requirements. Lead data quality programs, including validation, reconciliation, and audit readiness across all regulatory datasets. Oversee data lineage, traceability, and integration across RIMS, document management, safety, and quality systems.
• xEVMPD and PMS Data Ownership: Direct the end‑to‑end management of xEVMPD submissions, ensuring timely updates, accuracy, and alignment with EMA requirements. Oversee PMS data capture, maintenance, and reporting to support post‑marketing obligations and safety‑related submissions. Partner with Pharmacovigilance, CMC, and Regulatory Affairs to ensure consistent product data across all systems and submissions.
• Health Authority Correspondence Management: Lead the global process for capturing, tracking, and archiving Health Authority correspondence, ensuring complete, searchable, and audit‑ready records. Ensure correspondence metadata is structured and linked to submissions, commitments, variations, and product lifecycle events. Support regulatory teams in preparing data‑driven responses to Health Authority queries and inspections.
• CPP Management and Critical Document Ordering: Oversee the global process for requesting, tracking, and delivering Certificates of Pharmaceutical Product (CPPs) and related legalized documents. Ensure timely availability of CPPs and other critical documents to support global submissions, renewals, and market expansions. Manage relationships with manufacturing sites, affiliates, and external vendors involved in document issuance and legalization. Implement digital tools and workflows to streamline document ordering, tracking, and delivery.
• Cross‑Functional Collaboration: Partner with Regulatory Affairs, Safety, CMC, Quality, Supply Chain, and IT to ensure regulatory data is consistent, validated, and aligned across functions to drive continuous improvement, automation, and digital transformation of regulatory data and reporting processes. Represent regulatory data and support functions in global governance forums and digital transformation initiatives. Provide expert guidance on regulatory data impacts for new products, lifecycle changes, and market expansions.
• Leadership and Team Development: Lead a global team responsible for regulatory data operations, RIMS support, CPP/document management, and Health Authority correspondence and Q&A Management. Build capabilities in regulatory informatics, structured data, and digital tools. Foster a culture of data quality, operational excellence, and continuous improvement.

Qualifications

• Minimum: Degree or equivalent work experience
• Fluent English required (oral and written)
• Expert knowledge in regulatory affairs with a deep understanding of end‑to‑end regulatory processes and data flows across regulatory and key stakeholder functions
• Experience: 20+ years in regulatory operations, preferably in the generic field, with experience from Regulatory Affairs Strategy and Regulatory Operations
• Expert understanding of global and regional regulatory data models and structured data (ISO IDMP, SPOR, xEVMPD)
• Detailed operating knowledge of the Veeva ecosystem and its cross‑functional data dependencies and data model including existing and forthcoming AI agents and Automation models
• Highly experienced in methodology to translate regulatory requirements into scalable and robust processes
• Regulatory intelligence, risk management, digital enablement especially around automation of high volume transactional workloads

Desired Skills

• Documentation Management
• Proactivity
• Regulatory Compliance

You’ll Receive

• United Kingdom: Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
• Netherlands: Temporary employment for 1 year with probation period with flexible working, learning and development opportunities. Indefinite employment contract based on performance after the first year of employment.

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.