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Open nowPosted 2 days ago

RA Professional Biociden (risicoanalyse, analytische chemie, werkzaamheid)

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Where
Gent, Belgium
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Your applicationOpen nowRA Professional Biociden (risicoanalyse, analytische chemie, werkzaamheid)EURES job mobility portal · Gent, Belgium
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Share of postings closed within
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  2. 3.6%3 days
  3. 8.2%7 days
  4. 15.2%14 days
  5. 34.0%30 days
This job: posted 2 days ago

EURES job mobility portal median: 3 days open

The posting

Wij zijn op zoek naar een Regulatory Affairs Professional met expertise in risicoanalyse, analytische chemie en/of werkzaamheid.

Als Regulatory Affairs Professional maak je deel uit van een multidisciplinair team dat werkt binnen verschillende chemische regelgevingskaders (Biocidal Products Regulation, REACH, Plant Protection Products Regulation, …) en wetenschappelijke domeinen (chemie, toxicologie, gedrag van stoffen in het milieu, ecotoxicologie, werkzaamheid, fysico-chemie, …).

In deze rol:

  • Ondersteun je en draag je bij aan regulatorische projecten binnen de EU Biocidal Products Regulation (Verordening (EU) nr. 528/2012), zowel voor werkzame stoffen als voor biocidenproducten
  • Stel je (delen van) regulatorische dossiers op, in nauwe samenwerking met collega’s om wetenschappelijke en technische input te integreren
  • Pas je actief je expertise in werkzaamheid en/of analytische chemie/fysico-chemie toe ter ondersteuning van dossieropbouw, data-evaluatie, waiver- en bridging-onderbouwing en de overkoepelende regulatorische strategie
  • Beantwoord je en verduidelijk je regulatorische vragen van klanten, waarbij je complexe BPR-vereisten vertaalt naar heldere en toepasbare adviezen
  • Verleen je strategisch regulatorisch advies over trajecten voor werkzame stoffen en/of biocidenproducten, inclusief datastrategieën, indieningsroutes en risicogebaseerde besluitvorming
  • Onderhoud je contacten met bevoegde autoriteiten in de lidstaten en ECHA, zowel vóór als na indiening van dossiers
  • Volg je wetgevende, wetenschappelijke en procedurele ontwikkelingen binnen het biocidenkader en beoordeel je de impact ervan op lopende en toekomstige dossiers
  • Draag je bij aan het uitbouwen en onderhouden van klantenrelaties door het leveren van kwalitatief hoogstaand, wetenschappelijk onderbouwd advies
  • Ondersteun je de verdere groei van ARCHE Consulting door offertes en kostinschattingen voor te bereiden en nieuwe opportuniteiten te identificeren
  • Bouw en onderhoud je een professioneel netwerk binnen de biocidensector via deelname aan overlegmomenten, werkgroepen en conferenties

Minimum kwalificaties:

  • Masterdiploma en/of PhD in een relevante richting (bio-ingenieurswetenschappen, biologie, chemie, milieuwetenschappen, bioscience engineering, …)
  • Grondige kennis van de EU-regelgeving voor biocidenproducten en biocidenproductfamilies
  • Expertise in minstens één van de volgende domeinen: humane en/of milieugerelateerde risico-evaluatie voor biociden, analytische/fysico-chemische vereisten voor biociden, werkzaamheid
  • Ervaring met R4BP en IUCLID

Vereiste vaardigheden:

  • Klant- en servicegericht
  • Sterke time- en projectmanagementvaardigheden
  • Uitstekende schriftelijke en mondelinge communicatievaardigheden
  • Sterk analytisch denkvermogen
  • Flexibel, oplossingsgericht en leergierig
  • Vloeiend in het Engels (schriftelijk en mondeling)

Extra troeven:

  • Ervaring met aanverwante regelgeving (REACH/CLP, Medical Device Regulation, Plant Protection Products Regulation, …)
  • Affiniteit met of ervaring in business development
  • Kennis van andere Europese talen (Nederlands, Frans, …)
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