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Regulatory Affairs Publishing Specialist
Regulatory Affairs, Operations, Regulatory Operations Specialist, Regulatory affairs publishing
Vienna, Wien, W, Austria
The client is a leading company that specialises in Pharmaceutical products (pharmaceutical, biotech, medical devices). It has diverse teams, in dynamic environments. The company has restructured and continues to enjoy steady growth and stability.
In this role, you will maintain e-data management and publishing; completing major submissions; supporting and managing the lifecycle of submissions; generate, file and archive document in accordance with all applicable regulations and standards, your main duties will include:
- take leadership responsibilities
- leading the submission team
- assist in creation of SOPs
- identify and tackle issues such as resources, general process efficiencies, and document issues
- assist in developing the team through training schemes
The person should be open, honest, positive thinker, creative and ready to speak to clients and everyone involved in the process with confidence. Must have ability to communicate and present.
- 2 years experience with electronic data handling or submissions
- Experience of publishing tools such as "first doc" and "ISI Regulatory suite"
- Knowledge of regulations and processes
- Lifesciences degree
from €2750 pcm + comprehensive benefits package
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