Senior Specialist Regulatory Key Initiatives

Alphapharm Pty Ltd T/A Viatris

Northern Cross, Ireland
Eu regulatory frameworks
Ectd structure understanding
Regulatory information management systems
The Senior Specialist, Global Regulatory Operations key will be responsible for utilizing their SME Regulatory knowledge to stay proactively informed of key regulatory initiatives across the globe, with a focus on pan European regulations

Job Summary

  • The Senior Specialist, Global Regulatory Operations key will be responsible for utilizing their SME Regulatory knowledge to stay proactively informed of key regulatory initiatives across the globe, with a focus on pan European regulations.
  • Monitor and interpret global regulatory initiatives, with a strong focus on EU regulations (e.g. IDMP, eCTD 4.0, SPOR), ensuring the organisation remains compliant and informed.
  • At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Matching Summary

The Senior Specialist, Global Regulatory Operations key will be responsible for utilizing their SME Regulatory knowledge to stay proactively informed of key regulatory initiatives across the globe, with a focus on pan European regulations.

Skills & Requirements

Must-have

  • EU regulatory frameworks
  • eCTD structure understanding
  • Regulatory Information Management systems
  • interpret complex regulatory documentation
  • proactive continuous learning mindset

Nice-to-have

  • collaborative culture
  • courage and resilience
  • making a difference in the world
  • inclusive environment

Key Requirements

  • Bachelor’s degree or equivalent
  • Pharmaceutical industry experience
  • Regulatory Affairs or Regulatory Operations experience
  • Strong knowledge of EU regulatory frameworks
  • Working knowledge of IDMP and SPOR
  • Experience with RIM systems
  • Ability to manage multiple projects

Work Rights

Not specified

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