Senior Specialist Regulatory Operations And System Support

McDermott Laboratories Limited Viatris

Competitive salary; bonus scheme available; health...
Not specified
Eu regulations article 57(2) knowledge
Xevmpd data submission expertise
Regulatory information management systems experience
McDermott Laboratories Limited Viatris is seeking a Senior Specialist in Regulatory Operations and System Support to manage regulatory documentation and submissions, particularly focusing on xEVMPD/IDMP requirements. The ideal candidate should have a relevant degree and experience in regulatory submissions, with strong knowledge of EU regulations and the ability to work collaboratively across teams

Job Summary

  • The role supports the coordination of regulatory documentation and xEVMPD/IDMP submissions to health authorities globally.
  • Candidates will maintain data quality, respond to EMA queries, and contribute to regulatory systems projects for efficiency.
  • Viatris offers competitive salaries, bonus schemes, health insurance, and an inclusive environment focused on diversity and sustainability.

Matching Summary

Match Score: 85

McDermott Laboratories Limited Viatris is seeking a Senior Specialist in Regulatory Operations and System Support to manage regulatory documentation and submissions, particularly focusing on xEVMPD/IDMP requirements. The ideal candidate should have a relevant degree and experience in regulatory submissions, with strong knowledge of EU regulations and the ability to work collaboratively across teams.

Salary

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

Skills & Requirements

Must-have

  • EU regulations Article 57(2) knowledge
  • xEVMPD data submission expertise
  • Regulatory Information Management Systems experience
  • Document Management Systems proficiency
  • Health Authority query response capability

Nice-to-have

  • Collaborative team work across functions
  • Strong time management and prioritization
  • Ability to adapt to new technologies quickly

Key Requirements

  • Bachelor's degree in relevant discipline
  • 2-4 years of relevant regulatory experience
  • Proficiency with Adobe Acrobat and Microsoft Office Suite

Work Rights

Not specified

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