CMC Director

2 months ago


Cambridge, Ontario, Canada Mundipharma International Full time
CMC Director Opportunity at Mundipharma International

We are seeking a highly skilled CMC Director to lead our Regulatory Affairs Chemistry Manufacturing Control (RA CMC) efforts across EU and ROW. As a key member of our team, you will be responsible for managing and delivering RA CMC outcomes for our products, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:
  • Develop and implement RA CMC strategies that recognize risk and provide mitigations
  • Lead a team of permanent employees and contractors to deliver RA CMC objectives
  • Collaborate with internal and external partners to drive efficient technical regulatory stewardship of products
  • Ensure effective communication and acknowledgement of RA CMC strategies within the organization
  • Represent Mundipharma International in RA CMC focused agency negotiations and interactions
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
What We Offer:
  • Flexible benefits package
  • Diversity and inclusion
  • Opportunity to work with a dynamic team in a fast-paced environment

If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you.


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