Regulatory Affairs Officer
- Science Talents
Regulatory Affairs Officer
- Registration of medicines according to different European and national procedures in line with the stipulated deadlines.
- Writing and keeping registration files and documents up to date and coordinating to other departments such as Market Access, QA, Logistics, Marketing and Sales.
- Answering questions from the government regarding all file parts.
- Passing on information from registration files to internal and external customers so that the medicines and the relevant information on the market conform to the approved registration files.
- Entering into and maintaining partnerships with the other Novartis development centers in Europe,
- Maintenance of registration files with regard to the generic product portfolio by, among others:
- Collecting and interpreting information from Novartis and government sources that is important for the most effective implementation of the registration activities;
- Prepare, implement and handle national, mutual (MRP) and decentralized (DCP) recognition procedures;
- Maintaining existing registrations (MRP, DCP, national) by performing variations and 5 annual renewals;
- The preparation and checking of national registration documents required for registration;
- Answering questions (all parts of the file) from authorities during national registration procedures for self-prepared registration dossiers and during MRP and DCP procedures concerning national documents;
- To this end, the RAO will perform the following tasks:
- Organizing translations of package leaflets and labeling;
- Checking translations of package leaflets and labeling;
- Preparation and approval of texts for packaging material;
- Reporting changes to the file due to variations or five-year renewals, based on the timely preparation and transmission of change requests;
- Checking artworks;
- Update Registration database and RA Launchplan;
- Answering questions linked to tenders and other supporting tasks (such as drawing up shortened leaflets, etc.);
- Being responsible for the assigned RA projects and their implementation;
- Update of the available RA follow-up lists
- Diploma (industrial) pharmacist or equivalent studies in scientific direction
- Accurate, punctual, vigilant
- Open attitude
- Communication skills
- Dynamic, enthusiastic and motivated
- Team spirit
- Trilingual (Dutch, French and English) and knowledge of German
- Loyal and reliable
- Analytical skills and scientific knowledge
- Organizational talent and commercial thinking
- Leadership over own projects
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- Professional bachelor (Higher Education Short Type)
- Dutch, English, French
- Company car
- 5 October
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