Director Respiratory Regulatory Cmc

Alphapharm Pty Ltd T/A Viatris

Hands-on cmc authoring experience
Regulatory cmc for respiratory products
Global cmc submission documentation
The role involves cultivating sustainable relationships across stakeholders to drive aligned regulatory strategies for the respiratory portfolio

Job Summary

  • The role involves cultivating sustainable relationships across stakeholders to drive aligned regulatory strategies for the respiratory portfolio.
  • Candidates must possess mandatory hands-on experience in CMC authoring for initial registrations or post-approval variations.
  • Viatris offers competitive salaries, benefits, and an inclusive environment where employees can make a significant impact on patient lives.

Matching Summary

The role involves cultivating sustainable relationships across stakeholders to drive aligned regulatory strategies for the respiratory portfolio.

Skills & Requirements

Must-have

  • Hands-on CMC authoring experience
  • Regulatory CMC for respiratory products
  • Global CMC submission documentation
  • cGMP knowledge and compliance
  • Advanced written and oral communications

Nice-to-have

  • Life cycle management of inhaled products
  • Experience with combination product types
  • Strategic thinking and planning skills
  • Matrix team leadership experience
  • External regulatory environment engagement

Key Requirements

  • Mandatory hands-on CMC authoring experience
  • Specific knowledge in respiratory/inhaled product development
  • Proven ability to lead complex cross-functional projects
  • Advanced understanding of global regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter