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Task description- overall coordination and preparation of regulatory submissions and strategies
- manage the clinical trial submissions to competent authorities (CA) and ethic committees (EC) in Belgium, The Netherlands and France. Negotiate and communicate effectively with CA and EC to obtain timely approvals
- develop and maintain regulatory knowledge of European regulations
- manage transposition of international standards into company related requirements
- provide advise and guidance to staff in order to keep them informed of the regulatory approval process and status.
- trigger and collect the necessary document inflow in order to obtain timely regulatory approvals
- defend company business interest in international standardization groups
- implement QC and QA systems
Profile- minimum 2 year of experience in a similar function in a CRO and/or in the pharmaceutical sector
- excellent in social and interpersonal contacts
- able to handle multiple tasks to meet deadlines
- motivating people (coaching, counseling, mentoring)
- customer-oriented, enthousiastic, dynamic
- excellent in Dutch, French and English (oral as well as written)
- experience in Microsoft Office
Education, knowledge and experience- Msc Pharmacy, (Para) Medical Sciences, or equivalent by experience
- minimum 2 years of experience in a similar function (preferably in a SME)
Our offer
KasaConsult offers you a challenging job with an interesting salary and extralegal benefits within a pleasant work atmosphere and on a location without traffic jams.
Possibility of development of your personal skills via courses.
Please send your reaction preferably by e-mail to k.seldeslagh(at)kasaconsult.com
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