Informacje o stanowisku
Opis stanowiska pracy
Regulatory Affairs Associate
Warszawa
NR REF.: 1192919
One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals that would contribute to its success by joining the new team.We are looking for Regulatory Affairs associates that would be responsible for ensuring that patient information and packaging materials of parallel distributed products are efficiently maintained in correspondence with all legal requirements. You will help updating, monitoring and actively supporting our products throughout the entire product lifecycle.
Office location: WarsawHybrid model: 3 days office-based, 2 days home-office
Main responsibilities:
- Monitoring and updating our products throughout the entire product lifecycle (keeping text and layout updated)
- Maintenance and tracking of registration documents as well as packaging material files in various databases, including MS-Dynamics-AX
- Administrative tasks (documentation, filing, and archiving of documents as well as database maintenance)
- Communication with regulatory authorities in English.
- Editing of packaging materials required for repackaging/labelling (instructions for use, labels, folding boxes) in compliance with pharmaceutical and trademark requirements.
- Adjusting production specifications and packaging materials in our database system
- Creating mock-ups and colored copies for authority submissions.
- Hybrid cooperation with RA teams in both Germany and Denmark.
Requirements:
- A reliable and precise working style, with attention to detail. Someone who excels at structured work in complex processes, is preferred.
- Experience with maintaining databases, editing and tracking documents
- Team spirit, motivation, and a hands-on mentality.
- Willingness to develop new skills and acquiring new knowledge.
- English C1, Adobe package skills recommended, flair for/interest in Illustrator and Photoshop, InDesign, Experience with and interest in IT/working in databases.
What you39ll get in return
- Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
- Work in a hybrid model (3 days in the office per week)
- Potential for a permanent contract after an initial 3-month period.
- Comprehensive medical coverage through Medicover.
- Sports Card: Access to various sports facilities and activities.
- Life insurance coverage for added security.
- Opportunity to be involved in the transition of processes.
- Attractive and competitive salary.
Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.
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