Head of Regulatory Data Management and Support

Job Description Summary

At Sandoz our Purpose is pioneering access for patients

Job Description

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 dataspanning xEVMPD PMS IDMPaligned datasets RIMS content and Health Authority correspondenceis accurate compliant submitted on time managed in accordance with required legislation and readily accessible.

This leader also oversees and holds accountability for the endtoend 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.

Your responsibilities include but not limited to:

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 document across all regions to maximise dossier re-use and reduce overall assessment times leading to faster to market outcomes.

xEVMPD and PMS Data Ownership

• Direct the endtoend management of xEVMPD submissions ensuring timely updates accuracy and alignment with EMA requirements.

• Oversee PMS data capture maintenance and reporting to support postmarketing obligations and safetyrelated 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 auditready records.

• Ensure correspondence metadata is structured and linked to submissions commitments variations and product lifecycle events.

• Support regulatory teams in preparing datadriven 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.

CrossFunctional 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.

• Provide support and for import of complex document sets to support regulatory strategy and submission processes

• Knowledge of template design template management and document requirements to ensure a right first time approach to all internally authored submission documents (submission ready component process knowledge and understanding)

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

What youll bring to the role:

Essential Requirements:

• Minimum: Degree or equivalent work experience

• Fluent English required (oral and written)

• Expert knowledge of regulatory affairs with a deep understanding end to end regulatory processes and regulatory data flows across regulatory and key stakeholder functions

Experience

• Experienced global regulatory operations leader with 20 years of regulatory experience in roles of increasing accountability and complexity ideally in the generic field preferably with a combination of 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 and understanding of the Veeva ecosystem and its associated 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

Youll 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: We offer temporary employment for 1 year with probation period with flexible working learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.

Why Sandoz

Sandoz is the global leader in Biosimilar and Generic medicines a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost touching the lives of more than 1 billion people across 100 countries! While we are proud of our achievements we have an ambition to do more so that everyone can achieve the basic humanrightof good health.

With investments in new development capabilities production sites new acquisitions and partnerships wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost high-quality medicines sustainably.

Our momentum is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful careers where diversity of thought is welcomed and where personal growth is supported!

Join us help us make healthcare fairer and faster.

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.

#Sandoz

Skills Desired

Documentation Management Proactivity Regulatory Compliance

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1