Senior Specialist Regulatory Operations And System Support

McDermott Laboratories Limited Viatris

Competitive salary; bonus scheme available; health...
Not specified; based on the job description, it appears to be office-based or hybrid.
Eu regulations article 57(2) knowledge
Xevmpd data submission expertise
Regulatory information management systems experience
McDermott Laboratories Limited Viatris seeks 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 knowledge of EU regulations and experience with regulatory systems, contributing to the efficiency of regulatory operations

Job Summary

  • The role involves maintaining xEVMPD data and responding to EMA queries to ensure compliance with submission timelines.
  • Candidates will coordinate communication with MA Coordinators and third parties to complete outstanding actions according to regulatory requirements.
  • Viatris offers competitive salaries, bonus schemes, health insurance, and pension plans alongside excellent career progression opportunities.

Matching Summary

Match Score: 85

McDermott Laboratories Limited Viatris seeks 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 knowledge of EU regulations and experience with regulatory systems, contributing to the efficiency of regulatory operations.

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
  • SPOR and IDMP regulatory requirements
  • Document Management Systems proficiency

Nice-to-have

  • Collaborative team work across functions
  • Ability to adapt to new technologies
  • Strong time management and prioritization
  • Experience engaging health authorities

Key Requirements

  • Bachelor's degree in relevant discipline
  • 2-4 years of relevant regulatory experience
  • Proficiency in numerical calculations

Work Rights

Not specified

Tailored Resume

Cover Letter