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Open nowPosted 80 days ago

Regulatory Affairs Specialist

EURES job mobility portal131,145 open roles

Where
Antwerpen, Belgium
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Your applicationOpen nowRegulatory Affairs SpecialistEURES job mobility portal · Antwerpen, 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 80 days ago

The posting

Over de functie

Als Regulatory Affairs Specialist speel je een cruciale rol in de introductie, registratie en lifecycle management van farmaceutische producten. Je maakt deel uit van een multidisciplinair team dat ervoor zorgt dat producten voldoen aan de geldende nationale en internationale regelgeving en kwaliteitsstandaarden.

Je bent verantwoordelijk voor het opstellen en onderhouden van registratiedossiers, het beheren van technische en regulatoire documentatie en het ondersteunen van wijzigingen binnen de productieomgeving. Daarbij werk je nauw samen met verschillende interne afdelingen zoals Manufacturing, Quality Assurance, Supply Chain, Laboratories en Compliance, evenals met internationale Regulatory Affairs- en R&D-teams.

Dankzij jouw expertise in regulatory writing, stakeholdermanagement en projectcoördinatie draag je rechtstreeks bij aan de succesvolle introductie en verdere ontwikkeling van geneesmiddelen die patiënten wereldwijd bereiken.

Verantwoordelijkheden

  • Opstellen, onderhouden en indienen van registratiedossiers en regulatoire documentatie (CTD, BLA, NDA en variaties).
  • Schrijven en beheren van technische en CMC-gerelateerde documentatie conform internationale richtlijnen.
  • Adviseren van interne stakeholders over regulatoire vereisten en impactanalyses.
  • Evalueren van post-approval wijzigingen en bepalen van de noodzakelijke regulatoire acties.
  • Coördineren van dossierupdates en bijdragen aan lifecycle management van bestaande producten.
  • Ondersteunen van validatie-experten en andere technische teams bij documentatie- en compliancevraagstukken.
  • Beheren en opvolgen van vragen van gezondheidsautoriteiten en zorgen voor tijdige en kwalitatieve antwoorden.
  • Samenwerken met internationale Regulatory Affairs-, Quality- en R&D-teams om consistente dossiers en registraties te waarborgen.
  • Actief deelnemen aan audits, inspecties en auditvoorbereidingen.
  • Bijdragen aan continue verbetering van regulatoire processen en documentatiestandaarden.

Profiel

  • Masterdiploma in Life Sciences, zoals Industrieel Apotheker, Biomedische Wetenschappen, Bio-ingenieur of gelijkwaardig.
  • Minimaal drie jaar ervaring binnen de farmaceutische sector of gelijkwaardig door een relevante PhD.
  • Ervaring met regulatory affairs, dossieropbouw en technische documentatie.
  • Kennis van internationale registratiedossiers en CMC-documentatie.
  • Goede kennis van regelgeving en richtlijnen van onder andere EMA en FDA.
  • Sterke technische schrijfvaardigheden en oog voor detail.
  • Uitstekende analytische vaardigheden en een gestructureerde werkaanpak.
  • Ervaring binnen een gereguleerde omgeving en kennis van kwaliteitsprocessen.
  • Sterke communicatieve vaardigheden en het vermogen om stakeholders op verschillende niveaus te verbinden.
  • Vloeiend in Nederlands en Engels, zowel schriftelijk als mondeling.
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