Offers “Akka Technologies”

40 days agoAkka Technologies

Support in Regulatory Affairs Animal Health

  • CDD
  • BELGIUM

Job description

OVER ONS

AKKA Belgium, het Belgisch filiaal van de AKKA Technologies Group, is momenteel de nummer 1 in België in Industrial engineering consultancy en heeft bijna 1000 experts in dienst.

Al meer dan 30 jaar staat het bedrijf de grootste industriële spelers bij in alle stadia van hun projecten. Hierbij bieden wij een grote meerwaarde in snel evoluerende sectoren zoals lucht- en ruimtevaart, spoorwegen, automobielsector, life sciences, energie en hightech. Door onze expertise in deze sectoren bouwt AKKA Belgium mee aan de wereld van morgen.

Within AKKA Technologies we are looking for a  Support in Regulatory Affairs Animal Health  to join our team on a highly important mission.
Description:
You take care of supporting Regulatory Affairs (RA) activities of the RA Unit
Registration of products.
Contact with stakeholders inside and outside the company: you defend the interests of the company and you consider the requirements of the law and legislation and the business principles of the company.
You support Senior Regulatory Affairs Managers (RAMs) with specific RA matters between Global and the Dutch, Belgian and Luxemburg authorities.
Selecting relevant information from the Staatscourant in the Netherlands.
You support life cycle management of Veterinary Medicinal Products (VMPs). This concerns the following tasks:
Supporting the RAM in case of RA product procedures.
Communicating about RA procedures with Global RA (GRA) and the national authorities.
Controlling excel files with information on RA procedures or products.
Entering and checking of RA information on products.
Translating product information, i.e. Summary of Product Characteristics (SPC), leaflets, labels, boxes, etc.
You support 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 ARTIS and involves the following tasks:
Starting new packaging items (package leaflet, label and box) in ARTIS.
Changing existing packaging items and starting the ARTIS process flow.
Checking of correct packaging after asking product samples from the warehouse.
Controlling excel files with information on packaging items.
You are 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 Checking, starting and changing the VMP texts in the Repertorium and the E-compendium
You are responsible for applying for batch releases of vaccines at the national authorities and support in the release of product batches in the Benelux market. This involves the following tasks:
Filling in and submitting the batch release application to the national authority.
Communicating national authority batch approvals with the CDPs.
Controlling excel files with information on batch applications and releases.
You are also responsible for entering and following Product Quality Complaints (PQCs) and support the Sr. Pharmaco

 

 

Profile

Function requirements

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
Compliance and quality driven
An accurate and systematical way of working
Excellent speaking and writing capabilities of the Dutch, French and English language. Good writing capabilities of the German language

Als AKKA consultant,

Zal u:

·  Verantwoordelijk zijn voor diverse transversale projecten
·  Ondersteund worden in uw carrière door uw AKKA Manager
·  Controle hebben over uw trainingsplan en persoonlijke en professionele ontwikkeling
·  Lid zijn van een dynamische en samenwerkende gemeenschap van ingenieurs
·  Genieten van een permanent contract
·  Genieten van een competitief salaris pakket met verschillende extralegale voordelen

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