- Entreprise : Hikma Pharma
- Fonction : Santé, Médical, Pharmacie
- Secteur : Industries
- Lieu : Alger
Job Description: Pharmacist Regulatory Affairs Officer
Duties:
– Preparation and internal follow up of registration files of new imported products (Corporate files, under license files and Hikma subsidiaries files) until submission following the approved submission plan
– Preparation and internal follow up of registration files of new local manufactured products (R&D and Tech Transfer) Hikma Pharma Algeria and Dar Al Arabia until submission following the approved submission plan
– Preparation and internal follow up of “Renewal files” until submission following the approved submission plan.
– Preparation and internal follow up of “Variation files” until submission following the approved submission plan.
– Preparation of preliminary registration files of the new products planned for the local production (R&D and Tech Transfer) for submission to MOH
– Preparation of preliminary registration files of the new products planned for importation for submission to MOH
– Check of the therapeutic formularies and check of their translation which are part of the preliminary registration process
– Check of formularies and summary of product characteristics SPCc which is part of the preliminary registration process
– Follow up of the pricing process with the concerned departments ( Finance and Marketing) until obtaining the final approved proposed registration price
– Preparation of reimbursement files of the products following a new registration decision for the Ministry of Labor.
– Preparation of clearance files for registration purposes (samples and working standard clearance)
– Preparation of classification files (parapharmaceutical products) for submission to MOH
– Creation, update and maintenance of the regulatory affairs database to insure products history and a good traceability of the life cycle of the products.
– Creation and update of internal regulatory procedures following the local governmental guidelines
– Inform the corporate team and the company about any new regulations and guidelines applicable in Algeria
