Senior Regulatory Operations & Systems Specialist

Viatris; Lisboa; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Work-life balance

Job summary

Viatris is a global healthcare company seeking a Senior Specialist Regulatory Operations and System Support to coordinate regulatory documentation and xEVMPD/IDMP submissions. You will work with central teams and local affiliates to track registrations, manage submission status, and ensure regulatory and business needs are met.

You will contribute to regulatory systems projects and support broader project management while ensuring data quality and timely responses to health authorities.

Qualifications

• Bachelor's degree in a relevant discipline with 2–4 years of experience
• Strong knowledge of EU regulations, specifically Article 57(2), SPOR, and IDMP
• Proven expertise in xEVMPD data submissions and regulatory requirements
• Experience with Regulatory Information Management Systems (RIMS) and Doc Management Systems
• Experience engaging with health authorities and stakeholders
• Ability to manage multiple projects and meet timelines
• Numerical proficiency in percentages, ratios and rates

Responsibilities

• Maintain xEVMPD (Article 57) data using XEVMPD software and ensure data quality
• Respond to EMA and other Health Authority queries related to xEVMPD/IDMP data
• Provide registration tracking input aligned with regulatory requirements
• Coordinate with MA Coordinators and third parties to ensure timely actions
• Support XEVMPD system administration including user management and updates
• Perform reconciliation of xEVMPD/IDMP data with affiliates
• Monitor regulatory updates and implement in systems and processes
• Manage SPOR PMS data submissions and maintain product portfolio in the system

Skills

Regulatory operations

XEVMPD data

IDMP knowledge

RIMS

DMS

Adobe Acrobat

Microsoft Office

Stakeholder management

Time management

Education

Bachelor's degree in a relevant discipline

Tools

RIMS

DMS

Adobe Acrobat

Microsoft Office

Job description

Viatris is a global healthcare company seeking a Senior Specialist Regulatory Operations and System Support to coordinate regulatory documentation and xEVMPD/IDMP submissions. You will work with central teams and local affiliates to track registrations, manage submission status, and ensure regulatory and business needs are met.

You will contribute to regulatory systems projects and support broader project management while ensuring data quality and timely responses to health authorities.