Regulatory Affairs Officer

il y a 1 semaine


Vilvoorde, Flandre, 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 fiveyear 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 followup lists;
  • Request CNK codes for new launches
  • Startup and followup 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 followup 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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