Regulatory Affairs Specialist
Midlle East pharmaceuticals, Ghannam group , IBEX international & DKT International
Total des années d'expérience :4 years, 11 Mois
1- Responsible to ensure regulatory compliance for products and processes on company level Act as the interlocutors for regulatory functions at headquarter as well as main contact for all regulatory issues within the affiliate.
2-Responsible for seeking legal advice from external or internal lawyers in case of legal questions such as the regulatory classification of products or the legitimacy of claims Regulatory Compliance Ensure that products meet requirements of national legislation
Compliance of local artworks with national labeling requirements
Compliance of advertisement, especially use of claims, with national requirements Compliance with sales channel restrictions Ensure that local product handling activities (packaging/repackaging, storage, promotion activities, and sampling) meet regulatory demands Ensure full regulatory
3- communicate requests for registration dossiers to responsible corporate functions and/or PCs Transpose registration data and dossiers in required format. language and submit to authorities
4- Follow-up registration processes with local authorities and maintain existing registrations Forward required notifications, product dossiers to authorities and poison centers Regulatory Affairs Communication Monitor local regulatory developments and requirements.
5- Establish contacts with local authorities and act as primary contact for regulatory issues and trouble shooting
6- Check local requirements for new product development (e.g. product classification, regulatory clearance, specific packaging)
Master degree in pharmacology