CMC Director

1 day ago


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

We are seeking a highly skilled CMC Director to join our team at Mundipharma International. As a key member of our organization, you will be responsible for managing and delivering Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for our products across the EU and ROW.

Key Responsibilities:
  • Lead a team of permanent employees within CMC regulatory and supervise contractors and consultants to achieve RA CMC objectives and deliverables.
  • Develop and implement effective RA CMC strategies that recognize risk, provide mitigations, and ensure communication and acknowledgement within the organization.
  • Collaborate with internal and external partners to drive efficient technical regulatory stewardship of products.
  • Ensure that RA CMC activities are executed in accordance with regulatory requirements and industry standards.
  • Provide scientific-based leadership and guidance to the team to ensure the delivery of high-quality RA CMC outcomes.
Requirements:
  • Scientific-based degree in a relevant field.
  • 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 and innovative organization.

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