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Open nowPosted 80 days ago

Regulatory Affairs Manager

EURES job mobility portal280,773 open roles

Where
Gent, Belgium
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Your applicationOpen nowRegulatory Affairs ManagerEURES job mobility portal · Gent, Belgium
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  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 80 days ago

The posting

Insentials is een Belgisch merk dat zich toelegt op het aanbieden van hoogwaardige voedingssupplementen, ondersteund door wetenschappelijk onderzoek. Het bedrijf streeft naar het bevorderen van gezondheid en welzijn door middel van producten die de lever ontgiften, het metabolisme optimaliseren en inspelen op persoonlijke behoeften. Insentials biedt een unieke slow-release duo-capsule technologie voor een betere opname van vitamines en mineralen.

Functiebeschrijving Aangezien Insentials enorm aan het groeien is zoeken wij een: Regulatory Affairs Manager - Gent

Ben jij een gedreven Regulatory Affairs Manager met diepgaande kennis van de OTC-sector en farmaceutische wetgeving? Wil je werken in een dynamische omgeving waar innovatie, kwaliteit en compliance centraal staan? Dan zoeken wij jou! Regulatory compliance:

  • Begeleiden van productregistraties en waarborgen van naleving van de Europese en internationale farmaceutische wetgeving (EFSA, EMA, FAVV)
  • Actieve monitoring en implementatie van wijzigingen in wet- en regelgeving, inclusief novel food-wetgeving en farmaceutische richtlijnen.
  • Verzekeren van correcte wetenschappelijke onderbouwing en validatie van gezondheidsclaims conform EFSA-verordeningen.

Registratie & Marktautorisaties:

  • Opstellen, indienen en beheren van registratiedossiers bij gezondheidsautoriteiten o.a. FAVV.
  • Optimalisatie van autorisatieprocedures voor voedingssupplementen, incl. bio-equivalentie en farmaceutische stabiliteitsstudies.
  • Contact onderhouden met regelgevende instanties, onderzoeksinstituten en externe partners.

Verpakking regulariseren:

  • Controle en optimalisatie van productverpakkingen om te voldoen aan wetgeving en merkstandaarden.
  • Samenwerken met marketing en design om verpakkingen te laten aansluiten bij de wettelijke vereisten en merkidentiteit.

Productontwikkeling:

  • Samenwerken met R&D, marketing en sales om innovatieve en conforme producten op de markt te brengen en uit te leggen.
  • Initiëren en interpreteren van preklinische en klinische studies ter ondersteuning van de werkzaamheid en veiligheid van nieuwe productlijnen.
  • Publiceren van wetenschappelijke studies.

Marktanalyse:

  • Monitoring van trends in biomedische en voedingswetenschappen om marktgerichte productontwikkeling te stimuleren.
  • Uitvoeren van competitieve benchmarking en kritische analyse van wetenschappelijke data voor strategische positionering

Training & Compliance:

  • Opleidingen geven aan het commercieel team met focus op wetgeving, farmacologische werkingsmechanismen en claimvalidatie.
  • Advies en begeleiding bieden bij marketingcampagnes om naleving van regelgeving te garanderen.
  • Ondersteunen bij audits en inspecties door regelgevende instanties
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