Regulatory Affairs Officer

il y a 7 jours

Vilvoorde, Belgique Sandoz Temps plein

**Major Accountabilities**:

- Registration of medicinal products according to different European procedures (mutual recognition procedures (MRP) and decentralized procedures (DCP)) 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, Supply Chain, Marketing and Sales.
- Passing on information from registration files to internal and external stakeholders so that the medicinal products and the relevant information on the market conform to the approved registration files.
- Collecting and interpreting information from Sandoz and government sources that is important for the most effective implementation of the registration activities.
- Maintenance of registration files (MRP, DCP, national) by performing variations and 5 annual renewals.
- To this end, the RAO will perform the following tasks:

- Preparing and reviewing of national registration documents required for registration;
- Answering questions from authorities regarding national variations (all parts of the file) and national documents during MRP/DCP procedures/variations;
- Organizing translations of package leaflets and labeling;
- Checking translations of package leaflets and labeling;
- Preparation and approval of texts for packaging material;
- Initiating changes to the artwork 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 abbreviated SmPCs, review of the abbreviated SmPC in promotional materials etc.);
- Update of the available RA follow-up lists;
- Request CNK codes for new launches
- Start-up and follow-up of own RA projects and/or participate in projects.
- Local activities regarding Risk Management Plan (RMP)/Risk Management Activities (RMA)/Dear Healthcare Professional Communication (DHPC), such as the preparation, submission and follow-up of RMA/DHPC dossiers at the Belgian and Luxembourgian Health Authorities

**Education and Experience**:

- Diploma (industrial) pharmacist or equivalent studies in scientific direction
- 3 years in similar position

**Competencies**:

- Accurate, punctual, vigilant
- Open attitude
- Communication skills
- Autonomous
- 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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