Senior Specialist Regulatory Key Initiatives

McDermott Laboratories Limited Viatris

Competitive salary; bonus scheme; health insurance...
Strong knowledge of eu regulatory frameworks
Experience with regulatory information management systems
Understanding of ectd structure and idmp
The role involves monitoring and interpreting global regulatory initiatives with a strong focus on EU regulations like IDMP and eCTD 4.0

Job Summary

  • The role involves monitoring and interpreting global regulatory initiatives with a strong focus on EU regulations like IDMP and eCTD 4.0.
  • Candidates will lead cross-functional collaboration to improve data governance and support the implementation of IDMP templates.
  • Viatris offers competitive salaries, benefits, and an inclusive environment dedicated to building a diverse workplace.

Matching Summary

The role involves monitoring and interpreting global regulatory initiatives with a strong focus on EU regulations like IDMP and eCTD 4.0.

Salary

Competitive salary; Bonus scheme; Health insurance and pension

Skills & Requirements

Must-have

  • Strong knowledge of EU regulatory frameworks
  • Experience with Regulatory Information Management systems
  • Understanding of eCTD structure and IDMP

Nice-to-have

  • Proactive continuous learning mindset
  • Excellent attention to detail
  • Ability to present complex information clearly

Key Requirements

  • Bachelor's degree in pharmaceutical industry or equivalent
  • Experience in Regulatory Affairs or Regulatory Operations
  • Working knowledge of EMA procedures and XEVMPD

Work Rights

Not specified

Tailored Resume

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