Director Regulatory Cmc Sciences Project Management

Alphapharm Pty Ltd T/A Viatris

Competitive salary; bonus scheme available; health...
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Hands-on cmc authoring experience
Post-approval variation management
Site transfer regulatory strategy
** Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory CMC Sciences Project Management to oversee complex regulatory projects, particularly focused on manufacturing site transfers and alternate API sourcing. The ideal candidate will have extensive experience in regulatory affairs, project management, and strong communication skills, contributing to Viatris's mission to improve global healthcare access. **

Job Summary

  • The role serves as a regulatory expert managing global, large-scale manufacturing site transfers and alternate API sourcing activities.
  • Candidates must provide project management support for complex network optimization projects while coordinating priorities across multiple stakeholders.
  • Viatris offers competitive salaries, bonus schemes, health insurance, pension plans, and an inclusive environment focused on diversity and sustainability.

Matching Summary

Match Score: 75

** Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory CMC Sciences Project Management to oversee complex regulatory projects, particularly focused on manufacturing site transfers and alternate API sourcing. The ideal candidate will have extensive experience in regulatory affairs, project management, and strong communication skills, contributing to Viatris's mission to improve global healthcare access. **

Salary

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

Skills & Requirements

Must-have

  • Hands-on CMC authoring experience
  • Post-approval variation management
  • Site transfer regulatory strategy
  • Alternate API sourcing expertise
  • Matrixed team leadership

Nice-to-have

  • Strategic thinking in global markets
  • Mentoring and sharing experience
  • Advanced communication skills
  • Dashboard development capabilities
  • Collaborative culture fit

Key Requirements

  • Mandatory hands-on CMC authoring experience
  • Proven capability in managing complex Regulatory projects
  • Extensive knowledge of post-approval variations
  • Experience with cGMP assessment
  • Advanced understanding of global regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter