CMC Director

4 weeks ago


Dronfield, Derbyshire, United Kingdom Mundipharma Full time
About the Role

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

Key Responsibilities
  • Develop and implement RA CMC strategies that fully recognize risk, provide mitigations, and ensure effective communication within the organization.
  • Lead agency negotiations and interactions, including scientific advice, to ensure successful product registrations and lifecycle management.
  • Manage a team of permanent employees within CMC regulatory, providing clear performance and development objectives and delivering assigned RA CMC objectives.
  • Collaborate with internal and external partners to drive efficient technical regulatory stewardship of products.
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
What We Offer
  • Flexible benefits package
  • Opportunities for learning & development
  • Collaborative, inclusive work environment
Diversity and Inclusion

We are committed to building an inclusive environment where people can thrive, grow, and achieve their full potential.


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