At Zentiva, we are a team of 5000 unique talents bonded together by
our purpose to provide health and well-being for all generations.
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.
Join our winning team! Be part of our winning culture! Be Zentiva!
• Prepares and submits the necessary documents to the BDA according
to the normative requirements for obtaining permits for use of
medicinal products;
• Observes the deadlines established by the BDA for elimination of
incompleteness and / or discrepancies in the submitted
documentation for registration of the respective medicinal
product;
• Prepares written notifications to the BDA for the date of placing
on the market of the respective medicinal product, which has
received a marketing authorization, as well as in the cases of
planned or due to unforeseen circumstances suspension of the sales
of medicinal products. The notifications are agreed with the
Medical Director before their submission to the BDA;
• Creates, maintains and stores dossiers for each medicinal product
from the company's portfolio on electronic and / or paper
media;
• Creates, maintains and updates an internal databases on the
status of all procedures for issuing authorizations for use of
medicinal products;
• Informs in due time the Marketing and Sales Directorate for each
newly registered medicinal product, as well as for the occurred
changes in the brief characteristics, leaflets and packages of the
medicinal products;
• Participates in meetings organized by national regulatory
institutions
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