Ga naar hoofdinhoud

RA & Labelling Associate

Postulez ici

Laura Schollen
Career Manager



Laura Schollen
Career Manager
+32 494 04 21 32


Description de l'emploi

Comply with the Company’s policies and procedures to assure consistency of the current local prescribing information with the CCDS and/or EU labelling in order to:

  • Ensure alignment within the organization
  • Meet the expectations of regulatory agencies
  • Implement approved label through defined artwork process

Main Accountabilities

  • Act as Variations Officer & Carton & Label Operator (see separate function descriptions) 
  • Act as local expert for the available Regulatory Data Management Systems and ensure robust systems are in place for high quality data population
  • Work with the appropriate electronic systems soon after a new safety and indication/efficacy information becomes available or the content of the CCDS may change
  • According to the Company’s procedures, assess the documentation, propose the submission strategy and timelines to the Manager and then submit the change to the Regulatory Authorities. Appropriate communication within the organization should be done as required 
  • When new labelling is approved, work closely with appropriate electronic systems and Label centres to get labels developed, approved and implemented as per the required timeframe. Ensure coordination and maintain oversight of all labelling activities, including those performed by other team members 
  • Proactively communicate to RA Manager on potential issues
  • Work closely with Supply chain in order to anticipate any back order of the products on the market, provide regulatory input to Demand Review meetings
  • Assists in the Development  of Regulatory Affairs SOPs in compliance with the local regulation and internal policies and procedures
  • Liaise with Western European Regulatory Affairs and Corporate groups on regulatory and labeling matters


Profil

  • Education on A1 level
  • Several years Regulatory experience or in a related area in Healthcare industry
  • Project Management and Strategic Communication
  • Accurate end efficient
  • Organizational skills (proven experience) and sense for initiative
  • Able to perform multiple tasks and to establish priorities
  • Bilingual Dutch and French, good knowledge of English
  • Good general business sense
  • Adaptable to commercial and international environment
  • PC literate: Ms Word, Ms Excel, Acrobat


Postulez maintenant pour RA & Labelling Associate

Veuillez inclure vos coordonnées, votre formation et votre expérience afin que nous puissions voir rapidement si vous êtes le bon candidat pour le poste.

Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
+32 494 04 21 32