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Open nowPosted 9 days ago

Regulatory Affairs Officer

EURES job mobility portal119,031 open roles

Where
Gent, Belgium
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Your applicationOpen nowRegulatory Affairs OfficerEURES job mobility portal · Gent, Belgium

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on EURES job mobility portal's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

7.7% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.3%3 days
  3. 7.7%7 days
  4. 14.0%14 days
  5. 33.7%30 days
This job: posted 9 days ago

The posting

Als Regulatory Affairs Officer ben je verantwoordelijk voor het waarborgen van de naleving van alle Europese en nationale regelgeving met betrekking tot geneesmiddelen gedurende hun volledige levenscyclus. Je ondersteunt de voorbereiding, indiening en het onderhoud van registratiedossiers om markttoelatingen te verkrijgen en te behouden, zodat producten tijdig beschikbaar blijven op de markt en voldoen aan de geldende wettelijke vereisten.

• Voorbereiden, samenstellen en indienen van registratiedossiers (zoals marketing authorisation applications, variaties en hernieuwingen)

• Beheren van lifecycle management activiteiten voor geregistreerde producten conform de Europese regelgeving

• Toezien op de naleving van richtlijnen van de European Medicines Agency (EMA) en nationale gezondheidsautoriteiten

• Coördineren van antwoorden op vragen, opmerkingen en deficiency letters van regelgevende instanties

• Onderhouden en actualiseren van reglementaire documentatie, databanken en registratiesystemen

• Controleren van etikettering, SmPC's en bijsluiters op conformiteit met goedgekeurde dossiers

• Opvolgen van wijzigingen in wet- en regelgeving en beoordelen van de impact op bestaande producten

• Je beschikt over een masterdiploma in Farmaceutische Wetenschappen, Life Sciences of een verwante richting. Kandidaten met een bachelordiploma en relevante ervaring komen eveneens in aanmerking

• Je hebt minstens 2 jaar ervaring binnen Regulatory Affairs in de farmaceutische sector

• Je hebt ervaring met Europese en nationale registratieprocedures en beschikt over een grondige kennis van de Europese farmaceutische wetgeving, richtlijnen en regulatoire vereisten

• Je hebt ervaring met lifecycle management activiteiten, waaronder variaties en hernieuwingen

• Je hebt een perfecte mondelinge alsook schriftelijke kennis van het Nederlands. Daarnaast spreek en schrijf je vloeiend Engels. Kennis van Frans en/of Duits is een pluspun

• Je werkt gestructureerd en beschikt over sterke organisatorische en projectmanagementvaardigheden.

• Je hebt oog voor detail en werkt nauwkeurig

• Integriteit, kwaliteitsbewustzijn en compliance staan centraal in jouw manier van werken

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