CMC Director

2 months ago


Cambridge, Ontario, Canada Mundipharma International Full time
{"title": "CMC Director", "content": "Job Summary

We are seeking a highly skilled CMC Director to lead our Regulatory Affairs team in delivering high-quality products across the EU and ROW. As a key member of our team, you will be responsible for managing and delivering RA CMC outcomes, building strong partnerships with product teams, and ensuring effective delivery of CMC support from vendors.

Key Responsibilities
  • Develop and implement RA CMC strategies that recognize risk and provide mitigations
  • Lead agency negotiations and interactions, including scientific advice
  • Manage a team of permanent employees within CMC regulatory and supervise contractors and consultants
  • Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives
Requirements
  • Scientific based degree
  • Proven pharmaceutical experience in regulatory or technical CMC
  • CMC technical experience
  • Proven ability to drive efficient technical regulatory stewardship of products
About Us

Mundipharma International is a global pharmaceutical company committed to delivering high-quality products and services. We prioritize diversity and inclusion, creating an environment where employees can thrive and grow.

", "lang_code": "en-US"}
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