Regulatory Operations Specialist – IDMP & XEVMPD Systems

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 42 000 - 62 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Career progression

Work-life balance

Bonus scheme

Health insurance

Pension

Resumo da oferta

Viatris is seeking a Senior Specialist Regulatory Operations and System Support in Lisbon, Portugal. You will coordinate regulatory documentation and XEVMPD/IDMP submissions, liaise with central teams and local affiliates, and drive efficiency across regulatory systems projects under the project lead.

Key duties include data maintenance, responding to health authority queries, and coordinating with MA Coordinators to ensure timely actions.

Qualificações

• Bachelor's degree in a relevant discipline with 2–4 years of experience
• Strong knowledge of EU regulations including Article 57(2), SPOR and IDMP
• Proven expertise in xEVMPD data submissions and related systems
• Experience with Regulatory Information Management Systems (RIMS)
• Proficiency with Document Management Systems (DMS) and tools incl. Adobe Acrobat and MS Office
• Experience engaging with health authorities and external stakeholders
• Ability to work collaboratively across functions and manage time effectively
• Numerical proficiency with percentages, ratios, and rates

Responsabilidades

• Maintain xEVMPD (Article 57) data using XEVMPD software, ensuring data quality and timely submissions
• Respond to EMA and health authority queries regarding xEVMPD/IDMP data
• Provide registration tracking input per regulatory requirements
• Coordinate with MA Coordinators and third parties to complete actions on time
• Support XEVMPD system administration, including user management and updates
• Reconcile xEVMPD/IDMP data with affiliates as required
• Monitor regulatory updates and implement into systems and processes
• Manage SPOR PMS data submissions and maintain product portfolio

Conhecimentos

Bachelor's degree

EU regulation knowledge

xEVMPD submissions

RIMS

DMS and MS Office

Stakeholder engagement

Time management

Adapt to new tech

Numerical skills

Regulatory coordination

Formação académica

Bachelor's degree in a relevant discipline

Ferramentas

Adobe Acrobat

Microsoft Office Suite

RIMS

Descrição da oferta de emprego

Viatris is seeking a Senior Specialist Regulatory Operations and System Support in Lisbon, Portugal. You will coordinate regulatory documentation and XEVMPD/IDMP submissions, liaise with central teams and local affiliates, and drive efficiency across regulatory systems projects under the project lead.

Key duties include data maintenance, responding to health authority queries, and coordinating with MA Coordinators to ensure timely actions.