Regulatory Affairs Labeling Specialist
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
And what more?
The working schedule after the probation period is hybrid – up to 60% home office with minimum 40% presence in the office. And more other benefits are at your disposal, we look forward to presenting them over our further talks.
Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of almost 5,000 unique talents bonded together by our mission to deliver high quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. To learn more about our D&I commitment.
Join our winning team! Be a part of our winning culture! Be Zentiva!
