Détails de l'annonce
Référence:
160916
Publiée le:
8 août 2022
Lieu de travail:
Tunis, Tunisie
Expérience:
Entre 2 et 5 ans
Étude:
Bac + 5
Rémunération proposée:
1800 - DT / Mois
Disponibilité:
Plein temps
Langues:
Français , Anglais
Entreprise:
PRODUCTLIFE GROUP
Secteur: recrutement / ressources humaines
Taille: Entre 200 et 500 employés
Description de l'annonce:

In the context of a new project for one of our top Pharma clients, we’re looking for a talented consultant to lead the following missions, and much more!

Responsibilities:

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
  • Gain regulatory authority approval
  • Provide ongoing regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Provide regulatory support to clients and associate companies
  • Liaise with external regulatory authorities as required
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labeling
  • Review tasks for, support, and mentor Regulatory Affairs Associates
Profile:
  • Degree in Life Science/ Pharmacy degree would be a plus
  • First experience in Regulatory Affairs in the Pharmaceutical industry
  • Knowledge of Africa and/or MENA regulations for pharmaceuticals (NCE, Biologicals, and Biotech)
  • Excellent communication skills in English, French, and Arabic
  • Excellent attention to detail
  • Ability to work well within a multicultural team
  • Good time management skills