Description
I have an exciting opportunity with a leading CRO, working on the client site in the Middlands, for a 6 month contract to start within the next month. This is a full time contract.The role entails:
- Experience in CMC authoring and reviewing M3 sections of product registrations.
-Preparation and co-ordination of Clinical Trial Applications (CTAs)
-Compose high quality, global CMC clinical (IND/CTA) and marketing applications (NDA/MAA), including authorship in some sections
-The Candidate will be responsible for developing global Chemistry and Manufacturing Controls (CMC) regulatory strategy, writing high quality, global CMC clinical (IND/CTA) and marketing applications (NDA/MAA), and interacting with global Health Authorities to obtain timely approvals
If you are interested in this role, please do let Mina Ranavaya by sending through an updated CV, or alternatively do give me a call on .