The leading independent Czech pharmaceutical company with its own scientific research base for development of human drug products is looking for a suitable candidate for the position of: Global Regulatory Affairs Specialist. Your main responsibility will be, within the assigned registration projects, for all dossier management and coordination activities for the entrusted products.
Active management of registration projects during the whole life-cycle of the product (all types of processes - new registration, renewal of registration, variations, withdrawal of registration, sunset clause or its equivalent, etc.)
Ensuring the registration procedures are ongoing according to the registration plan
Compilation of the registration dossier and its subsequent processing in CTD, eCTD, NTA, ACTD, or possibly another dossier format according to the current legislative requirements of the country
Close cooperation with the Regulatory Zone Manager or Specialist in preparation of registration entry for new countries
Active participation on key company processes (change control management, risks assessment, reporting…)
Oversee maintenance and training of colleagues in operation of assigned software used for Regulatory purposes
Liaison and cooperation with internal departments and external partners
Degree in Pharmacy, Medicine or other Life Sciences
Basic knowledge of marketing authorization process of medicinal products and of the CTD dossier
Good knowledge of English language, any other language would be considered an advantage
Good organizational and communication skills
Flexibility and reliability, enthusiasm for learning new things
Previous experience in a similar position is an advantage, particularly with regards to marketing authorization applications and maintenance
Creative and diverse job in an independent, Czech pharmaceutical company, which is globally oriented
Notebook, mobile phone and a system of company benefits (5 weeks of vacation, contribution for pension insurance, contribution for public transport, meal contribution, Multisport card, contribution for language education, etc.)
Home office
Attractive and well-designed office in Brumlovka in Prague
Possibility of further self-education and self-development
Start of work immediately or upon agreement