Qualification and experience:
Specialized studies in Chemistry or Pharmacy;
Scientific vocational training;
Alternatively vocational training with experience in the field of Regulatory Affairs;
Sound knowledge of the legal framework for Regulatory Affairs in the EU and experience in national regulations for medicinal products.
Skills and attributes:
Very good written and spoken English skills;
Good communication skills and ability to work in a team;
Ability to work under own initiative and self-dependent, ability to make decisions;
Sense of responsibility, reliability and flexibility;
Experience in the use of electronic publishing systems and with the creation of eCTDs.
Preparation, checking, revising, finishing and maintenance of regulatory documents, . for variations and renewals;
Independent planning and implementation of maintenance and life cycle activities in the EEA and Switzerland ;
Communication and negotiations with the competent authorities;
Project management and reporting;
Deadline monitoring of approval projects;
Data maintenance in the marketing authorisation database;
Creation of registration dossiers with the help of electronic systems (DMS/Publishing).
Attractive salary package;
The opportunity to develop a career in a multinational industrial group;
Please send your CV in English.