Beschreibung
- You take on the preparation and implementation of national and international approval procedures- Independent supervision of groups of preparations in all questions relevant to approval with regard to quality, effectiveness and safety
- You will revise the product information texts such as instructions for use and technical information for submitting notifications of changes/variations for European (MRP/DCP) and national approval procedures
- You take care of the independent lifecycle management of approved products, as well as the implementation of change notifications/variations and the implementation of extension/renewal processes
- You will be responsible for project management in the development of new drugs and product transfers
Qualifications:
- University degree in pharmacy, biology or chemistry (or a comparable degree) and at least two years of professional experience
- Relevant experience in the field of regulatory affairs, especially in the area of maintaining European and national approvals
- Previous experience in project management is an asset
- Good MS Office Skills, knows of RA eSubmission tools is an advantage
- Ability to work in a team, analytical thinking, flexibility, assertiveness, communication skills