- The chance to work in a dynamic stimulating environment with a young and highly motivated team
- RA specialist role - key & central role within the team
- Based in Ghent region
- Play a key role in the regulatory information flow and follow-up on registration & compliance projects focussing on Europe
- Collect needed scientific data, prepare regulatory & risk assessments, registration dossiers, MSDS, and support label instructions for new and existing products within the aftermarket portfolio
- Follow-up on legislation and guidelines related to BPR, veterinary medicines and hygiene aftermarket in Europe
- Aftermarket Product Management, Regulatory Affairs & R&D colleagues (internal)
- Regulatory Authorities (external)
- Quality departments (internal)
- Contract labs and consultants (external)
- A university Degree in Sciences, Agricultural Sciences, Veterinary Sciences, or equivalent
- A minimum of 1-3 years' experience in Regulatory Affairs (dossier preparation & submission, compliance, GMP, ISO, manufacturing and quality control of chemicals or pharmaceutical products)£
- The ability to work independently but also interact in cross functional as well as cross cultural project teams
- A fluent knowledge of English and Dutch. Basic understanding of other languages (e.g. German, French, Spanish) is an asset
- Very good communication skills (verbal/written) and computer literate
- The opportunity to be part of a strong, international organisation
- A competitive salary with an attractive compensation package
- A flexible working schedule including home office
- The chance to work in a dynamic stimulating environment with a young and highly motivated team
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Regulatory Affairs Specialist - Ghent, België - Michael Page
Beschrijving
Our client has the vision to make sustainable food production possible.
As a company built on innovation, they constantly work to find ways of helping our customers, dairy farmers, do more with less by providing world-leading milking equipment and solutions.
They core values Passion, People, Professionals and Partnerships connect individuals across entities and geographies. Success is far more than knowledge - it is strongly related to behaviours. All guided by our three behaviours, Setting Direction, Make things happen.
Today, they are approximately 4,500 passionate professionals operating in more than 100 markets around the world.
In order to sustain their growth in EU, they are looking to extend their regulatory affairs team and add a strong team player to drive change & project internally & externally.
As the successful Regulatory Affairs Specialist, you will have the following responsibilities:
In This Role You Will Have Regular Contacts With
As the successful Regulatory Affairs Specialist - Veterinary, you will have the following requirements:
They offer you a workplace like no other, where state-of-the-art technology goes hand in hand with animal welfare.
Universities, Veterinary, GMP, Risk Analysis, Science, ISO Standards, Communication, Dossier Preparation, Manufacturing, Asset, Product Management, French language, Projects, Regulatory Risk, Aftermarket, Hygiene Regulations, Spanish language, German Language, Dutch Language, VOS, Veterinary Science, Quality Department, Chemicals, Registration, R&D, Legislation, Quality Control, Regulatory Affairs, Computer skills, Veterinary, Science, Pharmaceuticals