Head of Regulatory Data Management and Support

Overview

Job Description Summary 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.

They are 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. This leader also oversees and holds accountability for the end‑to‑end management of essential regulatory documents, including Certificates of Pharmaceutical Product (CPPs), legalizations, sample requirements and ordering, and other mission critical documents required from key functions and 3rd parties (e.g

QP declarations), ensuring timely availability to support global submissions and market access. The role drives continuous improvement, digital enablement, and data quality excellence across the regulatory ecosystem.

• 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.
• Responsible for the implementation and management of globalised templates for all regulatory submission documents across all regions to maximise dossier reuse and reduce overall assessment times leading to faster to market outcomes.
• 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 CPPs and related legalized documents; ensure timely availability 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; 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;…