Regulatory Affairs Specialist Veterinary Medicines

Il y a 5 mois


Deinze, Belgique Versele-Laga Temps plein

**Versele-Laga is a leading manufacturer of high quality food and care products for pet and performance animals with 10 factories in 3 continents. We sell our strong brands in over 85 countries thanks to our team of 1.100 colleagues with a true passion for animals. Our group headquarters are based in Deinze near Ghent. We produce more than 95% of our products in house starting from the best raw materials until the final packed product.**

**After more than 90 years of expertise since our founding, we are still a rock solid family owned company with a unique culture based on respect, passion and engagement. Our track record of strong growth continues in our long term ambitions based on innovation, high investments, regional expansion and off course our dedicated teams.**

**Every day, we are nurturing the bond between people and over 25 Million animals with the best nutrition and care products. We take our responsibility to improve the wellbeing of people and animals seriously through a wide range of initiatives. Next to that, we contribute to a better planet through local sourcing, lower CO2 emissions, energy and waste reduction.**

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**JOUW UITDAGING**:
- Obtain & maintain perfect knowledge of veterinary medicines legislation in EU and main export countries.-
- Maintain, review, approve and update regulatory dossiers in compliance with the veterinary medicines regulations in force-
- Preparation of submission of European dossiers in latest applicable format (renewals marketing authorisations, MRP)-
- Control packaging and labelling texts-
- Comply with relevant quality procedures-
- Assist the QPPV with Pharmacovigilance obligations: update PMSF, submission PSUR, reporting in UPD (Union Product Database),-
- Provide responses to regulatory agencies regarding product information or issues.-
- Manage activities such as audits, regulatory agency inspections.**YOUR PROFILE**:
- You have a Master industrial pharmacy, veterinary medicine, veterinary pharmacology or biomedical sciences-
- Good Knowledge of English on top of Dutch and French.-
- Good knowledge of European regulatory requirements for veterinary medicines-
- Content-related experience in several relevant areas of Regulatory Affairs-
- Autonomous approach to work, flexibility and dedication**WHAT WE CAN OFFER**:
- We offer a varied job in a growing international family business close to home.-
- You will receive a competitive salary, supplemented with fringe benefits.-
- Flexible remote work arrangements-
- Participation in sporting events such as the Versele-Laga run in Deinze, the Versele-Laga Classic, etc.-
- Opportunities for professional development and growth within the company-
- Family-oriented work environment with a strong sense of community



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