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Regulatory Affairs Officer

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Laura Schollen
Recruiter



Laura Schollen
Recruiter


Description de l'emploi

  • 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

Profil

  • Diploma (industrial) pharmacist or equivalent studies in scientific direction
  • 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

Offre

Permanent position

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