Gra Cmc Director - Marketed Products Development Lead

Takeda UK

Zurich, Switzerland
Regulatory submissions management
Cmc compliance expertise
Leadership in matrix environment
You will be accountable for developing and executing GRA CMC strategies for lifecycle management

Job Summary

  • You will be accountable for developing and executing GRA CMC strategies for lifecycle management.
  • The role involves managing regulatory submissions for global marketing applications and post-approval activities.
  • You will interact directly with international Health Authorities and facilitate agency meetings.

Matching Summary

You will be accountable for developing and executing GRA CMC strategies for lifecycle management.

Skills & Requirements

Must-have

  • Regulatory submissions management
  • CMC compliance expertise
  • Leadership in matrix environment

Nice-to-have

  • International experience preferred
  • Strong problem-solving ability
  • Teamwork and collaboration skills

Key Requirements

  • 10+ years pharmaceutical Regulatory CMC experience
  • BS/BA Degree in a Scientific Discipline
  • Expert in CTD authoring and review skills

Work Rights

Not specified

Tailored Resume

Cover Letter