Description
As the Regulatory Affairs Executive you will be involved in the writing and reviewing of module 1 - 5 for application submissions as well as maintaining product life cycle after the license is granted.Key Responsibilities:
- Developing and executing regulatory strategy for new products
- Preparing dossiers accurately for submission to governing boards as well as retaining and organising relevant licence documentation efficiently
- Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports
- Responsible for compiling regulatory documents including all Modules for submission according to local requirements
- Responsible for coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies
- Keeping up to date with regulatory issues in drug development processes and working to eliminate or minimise regulatory barriers
- Responsible for deficiency reply received from agency
- Maintenance of database with regulatory submission and approval
- Proactively keeping up to date with Regulatory guidance
The ideal candidate will hold a relevant life science or chemistry degree. They will also need knowledge/experience of completing a dossier for EU, through MRP, DCP and national procedures. Understanding of life cycle management and eCTD/Nees submissions are crucial.
For further information, please contact Karan Baxi on or via email on ka.baxi(a)realstaffing.com who specialises in placing RA professionals in varying levels of seniority.
Additionally, the wider Regulatory team have a range of roles that they are currently recruiting for so if you are looking for something other than this role, please do get in touch on .
To find out more about Real please visit www.realstaffing.com