Derks & Derks
Client orientated Regulatory Affairs position in the pharmaceutical industry
- joining a team of experts in Regulatory Affairs
- a challenging position with various responsibilities
- a social, but fast-growing and dynamic organisation
- serving an international client base
- permanent position, starting with a temporary contract
As Regulatory Affairs Manager you will be responsible for the overall regulatory compliance and submission of your products. You prepare and review all deviations and migrated data and make sure that they are compliant before submitting them to global agencies. Also, you will provide comprehensive data validation of dossiers prior to submission. You will also manage the access authorizations and ensure users’ training and update the work instructions. Furthermore, you will be responsible for general communication with the database supplier and keep track of developments in the submission field. Lastly, you will ensure the development and improvements to the systems (drugTrack and docuBridge).
- Bachelor’s degree or equivalent experience
- experience within Regulatory Affairs
- good knowledge of database management
- experience with medical product registration procedures (globally)
- good communication skills in English, both oral and written
Our client is a high-level pharmaceutical services organisation. They are specialized in the development and registration of high-quality pharmaceutical medicines/registration dossiers and are operating on a global level. They are highly motivated in their jobs. Their company culture characteristics are: informal, accessible and open minded. With different teams of highly skilled people they are a partner to all major generic players and innovative pharma industry for development and/or regulatory affairs/supply. It is their plan to expand over de coming year and hope to do so by building up their future team. Therefore, they are looking for an extra Regulatory Affairs Manager.
Interested? Please send your resume and motivational letter by e-mail, with reference to WL/22-052-DD to Sandra van Putten or Dennis Uleman: email@example.com.
For further information, please call, text or WhatsApp to Dennis Uleman at number +31 (0)6 82 72 71 33
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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