Regulatory Affair Business Unit
il y a 2 semaines
Department | Regulatory Affairs
- Full-time- Brussels- Alter Pharma Group NV**ABOUT OUR COMPANY**:
**Alter Pharma **is a Belgian group of pharmaceutical companies with headquarters in Anderlecht (Belgium) and offices in Ireland and the United States. Employing in total over 140 employees, the Group distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. At the same time, Alter Pharma is a global player on the generics market, with around 15 molecules on the European and US market and a fully stocked pipeline of niche, complex and added value products.
**OUR VALUES**:
Our talented staff daily work in accordance with our company values:
- We are proud of our entrepreneurial culture and foster open communication, mutual respect, professionalism and efficient decision-making and we believe that our multicultural organisation is one of our most important competitive advantages.
- We believe that timely and well considered decisions as a response to emerging opportunities and ideas is the key to our success.
- We believe that the success of the company lies in the competence, dedication and motivation of each of our employees.
- We believe that freedom returns flexibility and empowerment returns commitment.
**JOB DESCRIPTION**:
In order to help us proactively managing the lifecycle of the medicinal products for our parallel import business (pharmacy sales), we are currently looking for a talented RA Officer Artwork.
As a RA Officer Artwork, your main responsibilities are:
- You develop artwork in close cooperation with the design office.
- You prepare artwork for commercialisation or license/variation requests.
- Take into account the specific characteristics of the imported product, the lay-out and text of the Belgian reference product, legal comments and technical requirements.
- You verify if imported medicinal product batches our conform with the current license and take appropriate actions if not.
Furthermore, you manage the request, submissions and storage of medicinal product samples according to procedures. You print and assemble artwork prototypes (cartons, labels, ) with the internal printer and you update our RA databases. When necessary, you support the RA team in related tasks when needed.
You will work closely together with other departments (e.g. Legal, Supply Chain).
You will report directly to the companies’ RA Team Lead and will be based in Anderlecht, Belgium.
**YOUR PROFILE**:
- Experience in Regulatory Affairs and the pharmaceutical industry is a plus.
- You have excellent knowledge of Dutch and English, and a good knowledge of French.
- You have good knowledge of MS Office.
- You are a self-starter and capable of working autonomously and efficiently.
- You are a clear communicator and you have good administrative skills.
- You have a balancing entrepreneurial spirit and drive for performance (fast decision taking, positive, courage, curious, connected).
- You have eye for detail but still being able to keep the holistic view.
- You are flexible and able to work with deadlines.
- Team spirit is important for you.
**OUR OFFER**:
- A challenging function with a lot of variety, autonomy and responsibility.
- You work in a pleasant atmosphere in a dynamic team.
- A chance to grow and to have a real impact on our business.
- Being part of a highly innovative and fast-growing international player in the Life Sciences industry.
- We assure an optimal work-life balance including homework.
- We invest in your personal development.
- We offer an attractive salary package with a permanent contract and a package of fringe benefits including meal vouchers, group and hospitalisation insurance and a laptop.
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