Regulatory Affairs Reference number: 2353

  • Online since: 23-06-2022
  • Sector: Pharceutical
  • Start: 18-07-2022 | End: 31-12-2022
  • Category: Other

Job description

The Support in Regulatory Affairs reports to a RA Associate Director Benelux.

What you'll do

  • General Tasks:
    Participating in general RA meetings to be aware of RA activities on the one hand and to bring forward relevant RA topics on the other hand.
    - Taking care of the general RA inbox in Outlook.
    - Taking care of the general PV inbox in Outlook.
    - Scanning and sending documents.
    - Archiving of documents (on paper and/or electronically)
    - Digitalizing of paper dossiers of products.
  • Regulatory Procedures
    The contractor supports life cycle management of Veterinary Medicinal Products (VMPs). This concerns the following tasks:
    - Supporting the RAM in case of RA product procedures.
    - Controlling excel files with information on RA procedures or products.
    - Entering and checking of RA information on products on request of the RAM.
  • Packaging tasks
    The contractor supports the RAMs in keeping the leaflets and packaging materials of certain groups of products up to date. This involves working with the company’s packaging database and involves the following tasks:
    - Starting new packaging items (package leaflet, label and box) on request of the RAM
    - Changing existing packaging items on request of the RAM.
    - Reviewing if the packaging is correct
    - Controlling excel files with information on packaging items.
  • Repertorium and E-compendium
    The contractor is responsible for keeping up-to-date the RA texts of VMPs in e.g. the Repertorium (the Netherlands) and the E-compendium (Belgium). This involves the following tasks:
    - Checking the VMP texts in the Repertorium and the E-compendium on request of the RAM
    - Uploading new VMP texts in the Repertorium and the E-compendium on request of the RAM
    - Changing VMP texts in the Repertorium and the E-compendium on request of the RAM
  • Batch application & release
    The contractor is responsible for applying for batch releases of vaccines at the national authorities and supports in the release of product batches in the Benelux market.
    These tasks are administrative tasks and involve collaboration with the relevant RAM and Quality Assurance (QA) departments, as well as contact with the national authorities.
  • Pharmacovigilance
    The contractor is responsible for entering and following Product Quality Complaints (PQCs) and supports the Sr. Pharmacovigilance Managers (PVM) with Adverse Events (AEs).
  • Finance
    The contractor supports the RA Unit by taking care of invoices from national authorities for RA topics. These tasks involve collaboration with the RAMs and Associate Directors of Benelux, as well as contact with the national authorities.

Profile

  • Secondary or Higher Education in the Life Science field (secretaries, agricultural, laboratorial, etc.)
  • Knowledge and experience in the area of RA, preferably of veterinary medicines
  • Stress resistant and firm
  • Result Driven
  • Compliance and quality driven
  • An accurate and systematical way of working
  • Pragmatic and flexible
  • Excellent speaking and writing capabilities of the Dutch and English language
  • Notion of French and German is a plus

Required skills

Apply now
Mucella Pala Recruiter
02 629 77 74
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