Regulatory Affairs (System) Manager
Derks & Derks
Client orientated Regulatory Affairs position in the pharmaceutical industry
Offer
- joining a team of experts in Regulatory Affairs
- a challenging position with various responsibilities
- a social and fast-growing and dynamic organisation
- an international environment
- permanent position, starting with a temporary contract
- competitive salary package with attractive secondary benefits
Position
As a Regulatory Affairs (System) Manager your main responsibility will be the overall regulatory compliance and submission of your products. You prepare and review all deviations and migrated data and make sure that they are eCTD compliant before submitting them to global agencies.
You will also be responsible to keep track of and assess requirements and developments in the e-submission field (ao. eCTD, eAF, Art 57, SPOR). As system administrator of the EDMS and RIM (docuBridge and drugTrack) you are responsible for the general communication with the system supplier. Furthermore, you will ensure the improvement, installation, and validation of updates to the systems, writing of WIN/SOP and training of users.
In addition, you will be coordinating and managing the pre- and post-approval regulatory activities for registrations in the EU/US, and you will compile (authorize and review) the required CMC technical documentation in compliance with EU and US regulations and guidelines. Performing gap analysis on registration dossiers and indicate the regulatory implications of the analysis will also be one of your tasks as well as representing regulatory affairs in multidisciplinary project teams. Last, you identify, analyse and interpret relevant regulations, and guidance documents covering regulatory requirements for pharmaceutical products and drug-device combination products.
Profile
- 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
Organisation
Our client is a high-level pharmaceutical services organisation, specialized in technology transfers and the development and registration of high-quality generic and innovative products. They are operating on a global level. Their company culture characteristics are: informal, accessible and open minded. They are highly motivated in their jobs. It is their plan to expand over the coming years and wish to do so by building up their future team. Therefore, they are looking for a Regulatory Affairs Manager.
Response
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: info@derksenderks.nl.
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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