Partnering with a global pharmaceutical client, looking for a CTA Manager on a 12 month contract basis, starting in December.
EU Regulatory Affairs - CTA Manager
Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.
- Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments in the Europe (EU, UK and Switzerland). Support for rest-of-the-world clinical trial applications
- Contribute to the regulatory strategy by bringing the European insights into discussions
- Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal products
- Work with regulatory affairs consultants/service providers on CTA submissions
- Represent EU Regulatory Affairs at cross-functional study management team meetings
If you are interested in this longterm opportunity, please apply directly via the link.