CMC Director for Global Marketed Products

2 weeks ago


Cambridge, Ontario, Canada Mundipharma International Full time

About the Role

Mundipharma International is seeking a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW.

Key Responsibilities

  • Develop and implement RA CMC strategies for products, including oversight of vendor delivery.
  • Ensure RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making.
  • Act as escalation point for vendors for RA CMC strategy for products and review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided.
  • Provide RA CMC support for Due Diligence and responsible for RA CMC focused agency negotiations and interactions, including scientific advice.
  • Lead a team of permanent employees within CMC regulatory, ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio.

Requirements

  • Scientific based degree.
  • Proven pharmaceutical experience in regulatory or technical CMC.
  • CMC technical experience.
  • Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management.
  • Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.
  • Strong organisation and problem solving skills.
  • Self-motivated, driven with a positive attitude.
  • Excellent communicator and collaborator with strong customer and stakeholder focus.

About Mundipharma

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.


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