Assistant Manager, Regulatory Affairs Cmc (global)

Alphapharm Pty Ltd T/A Viatris

Not specified; not specified; competitive salaries...
Hands-on cmc authoring experience
Knowledge of cgmp requirements
Advanced written and oral communication skills
The role involves preparing regulatory assessments and contributing to global regulatory strategies for the Branded products portfolio

Job Summary

  • The role involves preparing regulatory assessments and contributing to global regulatory strategies for the Branded products portfolio.
  • Candidates must possess hands-on CMC authoring experience for initial registrations or post-approval variations.
  • Viatris offers competitive salaries, benefits, and an inclusive environment focused on diversity and sustainability.

Matching Summary

The role involves preparing regulatory assessments and contributing to global regulatory strategies for the Branded products portfolio.

Salary

Not specified; Not specified; Competitive salaries and benefits offered

Skills & Requirements

Must-have

  • Hands-on CMC authoring experience
  • Knowledge of cGMP requirements
  • Advanced written and oral communication skills
  • Experience with global regulatory guidelines
  • Microsoft Office Suite proficiency

Nice-to-have

  • Emerging awareness of new manufacturing technology
  • Subject Matter Expert in specific disciplines
  • Collaborative culture and resilience
  • Cross-disciplinary forum participation

Key Requirements

  • Mandatory hands-on CMC authoring experience
  • Solid understanding of development and commercial activities
  • Working knowledge of global regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter