Regulatory Affairs Officer

Jobinhalt

• 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
  
  

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

• 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