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Regulatory Affairs Manager

Employeur
S&You
Lieu
DIEGEM
Salaire
Competitive salaries and benefit packagesHospitalization and group insuranceHome workingBonus pl...
Date de clôture
30 oct. 2022

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Fonction
Secteur médical / Soins, Secteur médical - général
Secteur
Sciences - Recherche / Développement, Pharmacie
Type de contrat
CDI
Temps de travail
Temps plein
Niveau d'expérience
2 à 5 ans d'expérience
Langue(s) souhaitée(s)
Français

Détails de l'offre

Functieomschrijving

Our client is the 19th largest pharmaceutical company in Europe based in Diegem and is looking for a REGULATORY AFFAIRS MANAGER

You will be responsible for all regulatory activities within the organisation and report directly to the Country Manager

  • Obtain & maintain marketing authorizations in Benelux.
  • Put products on the market with a correct content of packaging components.
  • Follow-up of pricing & reimbursement dossiers.
  • Qualified Person for batch release.
  • Responsible for administrative control of products from EU and management of quality complaints and related aspects (SOP and legislation).
  • Back-up for Medical Director as contact person for Pharmacovigilance.
  • Support to Medical and Marketing Departments.
  • Coach the Regulatory Affairs Officer and Management Assistant.


Functie-eisen
  • Master’s degree in pharmacy or equivalent.
  • Several years of experience in regulatory affairs is mandatory.
  • Knowledge of regulations for pharmaceutical products
  • You have a good understanding of health economics, health outcomes and the ability to be articulated regarding these subjects.
  • Ability to work in partnership with key functions (Commercial, Controlling, …)
  • Accurate and efficient
  • Flexible, dynamic, organized, team player
  • Proficient in Dutch, French and English

Arbeidsvoorwaarden
  • Competitive salaries and benefit packages
  • Hospitalization and group insurance
  • Home working
  • Bonus plan
  • Meal+Eco vouchers
  • Mobility plan

Entreprise

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