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Zentiva as the champion of Generics and OTC medicines is headquartered in Prague and reaches over 40 million patients in 25 European countries. The growth of our organization brings new opportunities for our 2500 people to fulfil their potential. It also positions us well to attract best talent and retain our team to secure our success for future generations.
Regulatory Labeling Specialist
- Preparation and Maintenance of Product Labeling - Product Information (Summary of Product Characteristics -SmPC, Patient Information Leaflet -PIL, Labeling – text on packages) for dedicated portfolio in line with current scientific knowledge and legislation following development of clinical findings and safety requirements and drug legislation
- 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 update by relevant stakeholders with quality and timely mannered processes (for updates started after relevant regulatory body outcome, further safety signal via labeling review process, or in case of update CMC variations impacting labeling)
- Transversal support within global and site regulatory and labeling department on the products of its portfolio, their update and update implementation by affiliates, including the preparation, the provision of necessary documents and information
- Communication and coordination of related processes with internal partners and affiliates in particular countries
- Answering questions related to given part of registration documentation during registration procedures
- 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 while preparing clinical and nonclinical overviews in maintenance phase (changes, renewals)
- Supporting Pharmacovigilance in terms of preparing pharmacovigilance documents
- By above mentioned activities you will participate in whole life cycle of medicinal products (development, registration, launch, continuous updating of data during maintenance)
- Scientific university background, preferably in pharmaceutical 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.
- Ability to work with minimum supervision and escalate relevant information to management, capability of carrying out multiple tasks.
- Ability to effectively operate in a multicultural environment which requires negotiation, collaboration and adaptation
- Organizational Skills, capacity to work in network and to coordinate discussions to reach the objective on these subjects.
- Excellent (verbal / written) communication and relational skills with all the levels of colleagues and managers internally and in extern
- Capacity of fast adaptation, flexibility, sense for information sharing as like as big precision and concentration for the control of documents
- Technical Skills with the computing tools of Microsoft, tools of correction of documents as well as databases. Capacity of fast learning of new necessary tools for position missions.
- Advanced spoken and written English language
- An opportunity to work for a successful, fast growing international company
- Great learning and experience to work with an international pharmaceutical company
- An opportunity to expand knowledge and skills
- Above standard social and education program
- Fixed term contract – maternity cover