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工作内容
We are looking for a REGULATORY AFFAIRS MANAGER to manage veterinary and feed additive marketing authorisations of our sponsors and support on internal and external regulatory procedures. Responsibilities include, but are not limited to, the following:
- Advising and supervising regulatory procedures for veterinary medicines and feed additives (new applications, renewals, variations) in different markets of CRO clients (cfr Europe, US,...)
- Support clients with preparation and submissions of responses to the relevant regulatory authorities;
- Support in legislative matters regarding import and export of veterinary and feed additive products;
- Apply scientific, legal and business knowledge to support sponsors on product development, registration, manufacturing and distribution to meet legal as well as business requirements
Profil
THE IDEAL CANDIDATE
- Education: scientific, e.g. chemistry, pharmacy, biology or veterinary medicines;
- Knowledge/experience in the field of veterinary medicines and feed additive legislation (EMA, EFSA, FDA,...) would be an advantage;
- Knowledge/experience on GLP, GCP; GDP and/or GMP guidelines is a plus
- An exact and systematic, quality-driven way of working;
- Flexibility in working on several different tasks;
- Ability to cope with deadlines, persistent, result-driven;
- Ability to function as a valuable team member;
- Excellent communication and organization skills.
Connaissances linguistiques
Nederlands : Middelmatige
Engels : Middelmatige
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最后期限: 31-12-2025
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