Regulatory Affairs Specialist for Labeling
YOUR RESPONSIBILITIES:
* Preparation and Maintenance of Product Labeling
* Labeling End to End process management; change control management for labeling variation, responsibility for the actions to ensure the implementation of Safety and/or Efficacy Labeling
*Transversal support within global and site regulatory and labeling department on the products of its portfolio
* Communication and coordination of related processes with internal partners and affiliates in particular countries
* Preparation of specific documents for EMA, linguistic phase of CP management; participation in mock-up process for harmonized and centralized part of the procedure; ensuring of User testing
* Communication with external partners while testing readability of PIL and experts
* Supporting Pharmacovigilance in terms of preparing pharmacovigilance documents
WE REQUIRE:
* University background in pharmaceutical or medical field
* Experience in Regulatory Affairs, Pharmacovigilance, or Pharmaceutical Industry, an international interfaces experience would be a plus.
* Knowledge of Labeling Processes, regulatory requirements on the registration files, in particular as regards the updates of the labeling of products on the market.
* Organizational Skills
* Excellent (verbal / written) communication
* Fast adaptation, flexibility
* Technical Skills with the computing tools of Microsoft incl. databases
* Advanced spoken and written Czech/Slovak and English language