dimanche 29 décembre 2013
Pharmacist
- Entreprise : Hikma Pharma
- Secteur : Industries
- Lieu : Algérie, Alger
- Nombre de postes ouverts : 1
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
- 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
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