Director Respiratory Regulatory Cmc

Viatris

Not specified; not specified; competitive salaries...
Hands-on cmc authoring experience
Regulatory cmc for respiratory products
Global cmc submission documentation preparation
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 and regulatory affairs specifically for respiratory or inhaled products.
  • 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.

Salary

Not specified; Not specified; Competitive salaries and benefits mentioned

Skills & Requirements

Must-have

  • Hands-on CMC authoring experience
  • Regulatory CMC for respiratory products
  • Global CMC submission documentation preparation
  • cGMP knowledge for technical assessment
  • Advanced written and oral communication skills

Nice-to-have

  • Experience with combination product types
  • Strategic thinking in regulatory flexibility
  • Subject Matter Expert in respiratory domains
  • Matrixed team management experience
  • External stakeholder relationship cultivation

Key Requirements

  • Mandatory hands-on CMC authoring experience
  • Specific knowledge of 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