Strategic Director of Operations Home Based

3 weeks ago


Lydney, Gloucestershire, United Kingdom Mundipharma Full time
About the Role

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

The ideal candidate will have a proven track record in regulatory or technical CMC and excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management.

This role offers a flexible benefits package, opportunities for learning & development, and a collaborative, inclusive work environment.

Key Responsibilities
  • Ensure that 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.
  • 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.
  • Ability to effectively motivate and manage a team to deliver RA CMC objectives
What We Offer
  • Flexible benefits package
  • Opportunities for learning & development
  • Collaborative, inclusive work environment


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