CMC Regulatory Affairs Manager

Location United Kingdom
Contact name: Billy Twomey

Contact email: billy.twomey@medella.life
Job ref: 537
Published: 27 days ago

Job Description:

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.

Daily Tasks:

* 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

Desired Background:

* 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.