A global leader in sustainable antibiotics. Today they develop, produce and sell API’s and DP’s.
As Registration Professional you can hit the floor running, start as soon as possible and work fulltime for a period of one year.
- Preparing, compiling and maintaining the registration dossiers:
o Collection of information and preparation of dossiers
o Evaluation of the CMC data
o Creation of the product information texts
- Submitting the registration dossiers, responses, renewals and variation packages
- Coordinating the regulatory activities
- Contributing to the agreed way of document management
- Contributing to write and review the SOP’s
- Keeping excellent proactive relationships of DSP customers in order to maximize chances of approval.
- HBO or academic (WO) level
- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English