Regulatory affairs Specialist
Détails de l'annonce
Référence
181168
Date de publication
1 juillet 2023
Type de contrat
CDILieu de travail
Tunis, Tunisie
Expérience requise
Entre 2 et 5 ans
Niveau d'études
Bac + 3
Salaire proposé
Disponibilité
Plein temps
Langues
Arabe Français Anglais
Mobilité
Locale, Internationale
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Entreprise
Entreprise Anonyme
Secteur: santé / paramédical / optique
Taille: Entre 100 et 200 employés
Description de l'annonce
The jobs in this level are responsible to reviewing , analyzing and approving reports and registration files This level is involved with the development of procedures and contribution to policies and negotiating ; following with regulatory heath authorities to ensure meeting the submission –approval deadlines and enhancing country’s planned submission strategies execution.
Main tasks :
• Participates in the process of developing department procedures and contributing to the development of policies for the development of the department work and activities.
• Follows up regularly with authorities, internal departments and agents on related submissions and files to ensure meeting deadlines and negotiate with health authorities regarding the registration requirements to enhance execution of country’s planned submission strategies.
• Reviews, analyzes and approves reports related to registration, and regulatory affairs in general .
• Generates
annual registration plans covering new product registration and all maintenance
of registrations required per territory
• Evaluates agent performance from Regulatory point of view.
Education, experience and skills required:
• Pharmacist , scientific engineer or holder of a scientific master
• 5-7 years of experience
• Fluency in English
• Strong communication skills in both English and Arabic
Effective interpersonal skills
• Good leadership capabilities