Director Regulatory Affairs Global Cmc

Alphapharm Pty Ltd T/A Viatris

Competitive salary; bonus scheme available; health...
Not specified
Extensive hands-on cmc authoring experience
Leadership of matrixed technical teams
Deep knowledge of cgmp and global regulatory requirements
Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory Affairs Global CMC who will be responsible for developing strategic regulatory approaches related to Chemistry, Manufacturing, and Controls (CMC) for the L-Upjohn product portfolio. The ideal candidate should possess extensive CMC authoring, project management experience, and a strong understanding of global regulatory requirements

Job Summary

  • This role serves as an expert for global CMC regulatory knowledge to drive strategic approaches for the L-Upjohn product portfolio.
  • The successful candidate will manage resources, lead cross-functional project teams, and serve as a liaison with regulatory agencies.
  • Viatris offers competitive salaries, health insurance, pension plans, and diversity & inclusion initiatives alongside career progression opportunities.

Matching Summary

Match Score: 85

Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory Affairs Global CMC who will be responsible for developing strategic regulatory approaches related to Chemistry, Manufacturing, and Controls (CMC) for the L-Upjohn product portfolio. The ideal candidate should possess extensive CMC authoring, project management experience, and a strong understanding of global regulatory requirements.

Salary

Competitive salary; Bonus scheme available; Health insurance and pension included

Skills & Requirements

Must-have

  • Extensive hands-on CMC authoring experience
  • Leadership of matrixed technical teams
  • Deep knowledge of cGMP and global regulatory requirements
  • Experience with drug development lifecycle
  • Negotiation skills with regulatory authorities

Nice-to-have

  • Mentoring and talent development capabilities
  • Cross-functional stakeholder management
  • Participation in industry advisory committees
  • Strategic planning for complex projects

Key Requirements

  • Extensive years of mandatory hands-on CMC authoring experience
  • Extensive people and project management experience
  • Advanced understanding of global submission criteria and approval processes

Work Rights

Not specified

Tailored Resume

Cover Letter