Description
If successful, you will be responsible for- Supporting with review of Clinical Trial documents, looking at packages to determine the right documents are present
- Regulatory Intelligence, looking through other approved products, and their previous Clinical Trials
- Attending global meetings and supporting with taking minutes, so a good understanding of regulatory affairs is required
- Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions
- Working with the local operating companies in the region covered
- External communication to regulatory authorities in the region
- Conducting all of the operational activities relating to the project, which includes interacting with publishing and ensuring that the final submission package is ready for dispatch on time
You will cover both development compounds not yet licensed and the maintenance and further development of marketed compounds. The prime responsibility for compounds is with the EMEA Regulatory Liaison, who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.
You will work on the practical aspects of the compounds assigned, from MAA preparation, variations, renewals, PSURs or briefing packages for Scientific Advice and regulatory support for Clinical Trials etc., depending upon the life cycle of the compounds assigned. You may work on one or several compounds depending upon the work required for any compound at the time.
Essential:
- Operational knowledge of compiling a regulatory submission is helpful but the ability to review scientifically is also needed.
- Broad mid-level regulatory expertise in drug development (particularly with products in phase 2/3), and experience of CTA and clinical trial designs
- Experience of European Procedures, particularly Mutual Recognition Procedure and Centralised Procedure essential
- Good communication skills as there will be a number of teleconferences