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Regulatory Affairs Officer

il y a 1 mois

Oostende, Belgique Metagenics Temps plein

**Metagenics, producent van hoogwaardige micronutritie, is een wereldwijd actieve groep met eigen vestigingen in de Verenigde Staten, Australië, Nieuw Zeeland, België, Nederland, Luxemburg, Italië, Frankrijk, Japan, Canada en met distributeurs in tientallen andere landen.**

Metagenics Europe bedient de volledige Europese markt vanuit het hoofdkwartier in Oostende. Naast een **productie
- en distributielijn**, huisvest Metagenics er ook **een eigen Research and Development** afdeling en een **kwaliteitslaboratorium**.

In Europa zijn we één van de snelst groeiende OTC-bedrijven met sterke merken als ImmuDefense®, Bactiol®, MetaRelax®, MetaSleep®, CurcuDyn® en MetaDigest®.

**What you excel at every day**:

- As a 'Regulatory Affairs Specialist' you will be responsible for conducting and submitting product notifications for dietary supplements in the various countries in which we operate. You are also responsible for comments and liaising with the authorities where necessary. You follow up the relevant new legislation and help to implement this within the company.You are part of the Science department of Metagenics.

**Tasks**:
- Prepare and process all documentation for successful submission of notifications to ensure timely submission to appropriate regulatory agencies.
- Review product claims and evidence/labeling/advertising for compliance with country specific regulations.
- Approve - labels and all various types of marketing materials
- Provide support and/or coordinate with Regulatory Affairs staff to meet business needs
- Approve regulatory acceptability of proposed ingredients and/or formulations for NPD and EPD and Change Controls
- Keep abreast of current and proposed regulations specific to the assigned country/countries, in the context of this vacancy this will be UK/IRE and ITA to start.
- Coordinate with external parties such as approved regulatory consultants as needed.
- Provide support to the manager and/or head of the regional department.
- Prepare and process appropriate documents for departments
- Update internal SOPs and forms
- Coordinate and manage specific regulatory and operational projects within the team

**We are looking for the following profile**:
- You have a master's degree: science, pharmacis, (bio)chemistry, nutritional science....
- 2 to 3 years of relevant experience in food supplements is an advantage.
- You are fluent in Italian and English
- You are hands-on
- You work accurately
- You have a healthy dose of enthusiasm and are a team player**We provide these conditions**:

- You will have the opportunity to work with high quality products in a vibrant, international growth company, within a team of driven and passionate colleagues.Within Metagenics, you get the opportunity to grow and develop your knowledge and career. An attractive salary complemented by fringe benefits, including:
- Meal vouchers
- Group insurance
- Hospitalization insurance
- Possibility to telecommute two days a week + internet allowance
- Possibility for a company car
...