Global Regulatory Affairs Specialist

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.

JOB DESCRIPTION:

• 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

REQUIREMENTS:

• 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

WHAT DO WE OFFER?

• 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