Senior Specialist Regulatory Operations and System Support

About the role

Viatris is hiring a Senior Specialist Regulatory Operations and System Support in Lisbon. The role supports the coordination and management of regulatory documentation and XEVMPD/IDMP submissions to health authorities, working closely with the central organisation and local affiliates. It covers tracking registration activities, managing submission status reporting and contributing to regulatory systems projects.

Key responsibilities

• Maintain xEVMPD (Article 57) data using XEVMPD software, ensuring data quality and compliance with submission timelines.
• Respond to EMA and other health authority queries on xEVMPD/IDMP data accurately and on time.
• Provide registration tracking input according to external and internal regulatory requirements.
• Coordinate with MA Coordinators and third parties to complete outstanding actions on schedule.
• Support xEVMPD system administration, including user management and system updates.
• Reconcile xEVMPD/IDMP data with affiliates and monitor regulatory requirement updates.
• Manage SPOR PMS data submissions and maintain the product portfolio in the system.

Required profile

• Minimum Bachelor's degree (or equivalent) in a relevant discipline, with 2-4 years of relevant experience.
• Strong knowledge of EU regulations, especially Article 57(2), SPOR and IDMP.
• Proven expertise in xEVMPD data submissions, associated systems and regulatory requirements.
• Experience with Regulatory Information Management Systems (RIMS).
• Experience engaging with health authorities and stakeholders outside your own function.
• Ability to work collaboratively across functions and projects, manage time and priorities, and adapt quickly to new systems.

Required skills

• Document Management Systems (DMS)
• Adobe Acrobat and the Microsoft Office Suite
• Numerical tasks such as calculating percentages, ratios and rates

What we offer

• Competitive salary and benefits package
• Career progression opportunities
• Work-life balance initiatives and bonus scheme
• Health insurance and pension