Assistant Manager, Regulatory Affairs Cmc (global)

Viatris

Hands-on cmc authoring experience
Knowledge of cgmp requirements
Global regulatory strategy development
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 where employees can make a significant impact on patient lives.

Matching Summary

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

Skills & Requirements

Must-have

  • Hands-on CMC authoring experience
  • Knowledge of cGMP requirements
  • Global regulatory strategy development
  • Advanced written and oral communication skills
  • Microsoft Office Suite proficiency

Nice-to-have

  • Emerging awareness of new manufacturing technology
  • Ability to serve as Subject Matter Expert
  • Collaborative culture and resilience
  • Experience with Documentum-based applications

Key Requirements

  • Mandatory CMC authoring experience
  • Solid understanding of cGMPs
  • Working knowledge of global regulatory requirements
  • Demonstrated commitment to scientific integrity

Work Rights

Not specified

Tailored Resume

Cover Letter