The Role
1. Provide regulatory support for all activities conducted by the Company including dossier compilation, variations, change impact assessment, scientific advice applications, paediatric investigation plans, PSUR submissions.
2. To manage the generation and maintenance of Registration Dossiers (MAA/CTD) related with the products manufactured, in compliance with applicable legislations.
3. To develop the regulatory strategy for new submissions.
4. Working on EU projects within centralised procedures
You
5. Ideally 5 years’ experience (or equivalent) working in Pharma Regulatory Affairs
6. Experience of the centralised procedure for new products (EMA).
7. Working knowledge of the Common Technical Document (CTD).
8. Experience of directly dealing with Regulatory agencies.
9. Experience of scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.
10. Experience in gaining and maintaining product licences in the USA is desired but not essential.