Regulatory Affairs Officer

il y a 2 semaines

Asse, Flandre, Belgique Novellas Healthcare Temps plein
Freelance

  • Pharmaceutical
  • Are you interested in a project within Regulatory Affairs for a Top 10 biopharmaceutical company? Do you like administrative work and doing this in a processoriented and precise manner? Then this is your chance

Vacancy information:

As Regulatory Affairs (RA) Officer, you are responsible for executing operational administrative RA activities. You will report to the Head or RA and you will work very closely with an experienced RA Officer.

Accountabilities:

  • Assists the RA Manager/Officer upon preparation of the registration dossier, updates and/or variations thereof for submission at the Belgian and Luxembourg health authorities:
  • Among other editing and/or correcting cover letters, completing templates, modification of documents related to marketing authorisation, editing of product information with track changes
  • Modification of documentation in line with the instructions of the RA Manager/Officer
  • Use of the documentation databases according to the current processes and procedures
  • Creation of the electronic submission documents
  • Archiving of all correspondence (internal and authority correspondence)
  • Creation of consolidated approved dossiers (both paper and electronic version)
  • Organising and review of translations of the product information (DU
  • EN)
  • Collect answers and respond to regulatory authorities questions within required timelines
  • Review and correction of product information on Compendium portal
  • Update of internal databases (e.g. product database) and creation of such databases upon necessity
  • Request of modifications and review of the changes made in the company's registration tool
  • Assisting Head of RA-QA, QA Manager, and QA administrator with support for communication due to complaints and/or recalls
  • Supporting the QA team with internal classification of documents
  • Management of invoices from the RA/QA department.

Requirements information:

  • Bachelor or equivalent combination by education and experience
  • A first experience in Regulatory Affairs is an asset
  • Experience working with data entry systems
  • You like to work in a precise, structured and processoriented way
  • Good spoken and written communication skills Dutch and English (French is a strong asset)
  • Accuracy
  • Integrity/confidentiality
  • Flexibility
  • Customer/Market minded
  • Showing initiative
  • Planning and organisation.

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