Regulatory Affairs Specialist job opportunity at Zentiva.

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DatePosted 24 Days Ago bot
Zentiva Regulatory Affairs Specialist
Experience: 2-years
Pattern: full-time
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loacation Czechia / Praha, Czechia
loacation Czechia / Prah..........Czechia

Are you passionate about pharmaceutical legislation and want to play a key role in bringing quality medicines to patients? Join Zentiva as a Regulatory Affairs Specialist and become part of a collaborative, international pharma environment. Grow your regulatory career in a stable international pharmaceutical company where your work truly matters. Your Responsibilities Portfolio Management:  Oversee a portfolio of human medicinal products registered in EU and non-EU countries. Manage products registered via national, MRP/DCP, and CP procedures Post-Approval Activities:  Variations, renewals and withdrawals in line with regulatory guidelines. Manage post-approval commitments. Support the New Submission Team with territory extensions ( Non EU, RUP) Dossier Preparation & Submission:  Prepare high-quality registration dossiers ensuring compliance with regulatory requirements and health authority expectations. Check provided documentation and publish according to country-specific requirements (eCTD, NeeS). Submit registration documentation to authorities such as EMA, SÚKL, BfArM, MHRA, AIFA, etc. Utilize electronic submission portals such as CESP and Synplicity for regulatory filings Communication & Collaboration:  Maintain external communication with licensors and manufacturing sites Collaborate internally with production, supply, quality, development, labelling, pharmacovigilance and other teams to gather documentation for changes Compliance & Monitoring:  Ensure registration documentation complies with applicable legislation. Monitor and evaluate regulatory changes impacting products Data Management:  Maintain and update internal databases of registration data throughout the product lifecycle. We require University degree in chemistry/natural science/pharmacy Ideally work experience in regualtory affairs at least 2 years Professional Knowledge and Skills Knowledge of the European DRA legislation Decision-making skills Applicable legal requirements Communication and organizational skills Fluency in Czech and English What is in it for you An opportunity to work for a successful international pharmaceutical company. An opportunity to learn newest approaches in managing creative and highly adaptive business organizations. Pleasant and dynamic working environment. Continuous personal development. An attractive compensation & benefits package. Above standard social and benefit program.

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