CMC Director

6 days ago

Cambridge, Ontario, Canada Mundipharma International Full time
About the Role

We are seeking a highly skilled CMC Director to lead our Regulatory Affairs team and drive the delivery of RA CMC outcomes for our products across EU and ROW.

Key Responsibilities
  • Manage and deliver RA CMC strategies that fully recognise risk and provide mitigations
  • Build and maintain strong collaborative partnerships with product teams, particularly with Tech Ops and Quality
  • Act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors
  • Lead a team of permanent employees and supervise contractors and consultants to achieve CMC regulatory objectives and deliverables
  • Ensure RA CMC strategies are communicated and acknowledged within the organisation for appropriate product team decision making
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 working in collaboration with internal and external partners
What We Offer
  • Flexible benefits package
  • Diversity and inclusion
  • Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority

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