Senior Specialist Regulatory Operations And System Support

Viatris

Competitive salary; bonus scheme available; health...
Not specified
Xevmpd data submissions
Eu regulations article 57
Regulatory information management systems
Viatris is seeking a Senior Specialist in Regulatory Operations and System Support to manage regulatory documentation and submissions to health authorities. The ideal candidate will have a strong background in EU regulations and experience with xEVMPD data submissions, contributing to the company’s mission of improving global healthcare access

Job Summary

  • The role involves coordinating regulatory documentation and xEVMPD/IDMP submissions to health authorities while ensuring data quality and compliance.
  • Candidates will support XEVMPD system administration, manage user access, and perform reconciliation of data with affiliates.
  • Viatris offers competitive salaries, bonus schemes, health insurance, pension plans, and excellent career progression opportunities in an inclusive environment.

Matching Summary

Match Score: 85

Viatris is seeking a Senior Specialist in Regulatory Operations and System Support to manage regulatory documentation and submissions to health authorities. The ideal candidate will have a strong background in EU regulations and experience with xEVMPD data submissions, contributing to the company’s mission of improving global healthcare access.

Salary

Competitive salary; Bonus scheme available; Health insurance and pension included

Skills & Requirements

Must-have

  • xevmpd data submissions
  • eu regulations article 57
  • regulatory information management systems
  • health authority query response
  • sporr pms data management

Nice-to-have

  • collaborative team environment
  • strong time management skills
  • adaptability to new technologies
  • numerical calculation proficiency

Key Requirements

  • Bachelor's degree in relevant discipline
  • 2-4 years of relevant experience
  • Strong knowledge of EU regulations Article 57(2) SPOR IDMP
  • Experience with Regulatory Information Management Systems RIMS

Work Rights

Not specified

Tailored Resume

Cover Letter