Senior Manager, Regulatory Affairs Cmc

McDermott Laboratories Limited At VIATRIS

Northern Cross, Ireland
Cmc authoring experience
Global regulatory strategies
Prepare cmc submissions
Ensure global regulatory compliance with external requirements and internal quality procedures across all markets

Job Summary

  • Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.
  • Prepare, review, and deliver high-quality CMC submissions for new registrations, post-approval changes, renewals, and responses to agency queries.
  • Viatris empowers people worldwide to live healthier at every stage of life.

Matching Summary

Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.

Skills & Requirements

Must-have

  • CMC authoring experience
  • global regulatory strategies
  • prepare CMC submissions
  • regulatory compliance
  • cross-functional project teams
  • technical and scientific resource

Nice-to-have

  • courage and resilience
  • collaborative culture
  • sustainable operations
  • innovative solutions
  • healthier communities

Key Requirements

  • Hands-on CMC authoring experience
  • Advanced technical, functional, and industry knowledge
  • Advanced knowledge of regulatory requirements
  • Advanced skills in written & oral communications
  • Computer literacy with Microsoft Office Suite and Documentum-based applications
  • Project Management skills

Work Rights

Not specified

Tailored Resume

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