Medella Life is partnering with a global Biotechnology company who is seeking a CMC Regulatory Affairs Manager to join their West London branch on an initial 12 months contract with the opportunity to extend.
* Rollout of variations in EU, Switzerland, Israel, UK and Balkans countries.
* Support for clinical programs including additional responsibilities
* Support for new MAAs, RTQs and post approval maintenance in EU regions
* Preparation for two MAA's
* Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in Europe including, UK, Switzerland, Balkans and Israel.
* Deliver the CMC components for CTAs, marketing applications, variations and renewals
* At least 3 years experience within a CMC Regulatory Affairs position
* Be able to prepare and finalise CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
* Legally authorised to work in the UK.