Job title: registration specialist reports to: registration manager
Job code: date: \ \ department: registration
Salary grade:
Job summary
Prepare everything related to the preparation of the registration
company's files (pharmaceutical & medicines), even access to final registration file and get notified Date (notified registration no).
Main responsibilities
1. To prepare the (pharmaceutical & medicines) registry files
which include the flowing steps, - Preparation of (pharmaceutical &medicinal) documentation such as ( Product Composition index - analysis certification – analysis method - pharmaceutical stability study ) which prepared by a pharmacist 2. Provide the registry files of the Central Pharmaceutical Affairs in order to get notified Date. 3. follow up any observations of the parties, which will be to register about pharmaceutical product to do and modified it to meet the registration requirements 4. Prepare the product category type 5. Prepare the internal compendium of the product (In English and Arabic) And compliance (the known pharmaceutical standard products ) with required registration of the pharmaceutical product 6. To prepare the clinical studies of the product, to know Pharmacological therapeutic or interventions. 7. To prepare the pharmacology study 8. Address research centers to prepare (Research study required & Bioequivalence) of the pharmaceutical product to find out the financial offer and the required time period. 9. Formatting the registration file in terms of (spacers – cm) which depend on the type of category. 10. Provide registration file which include the flowing steps - Query phase (inquiry) with active ingredient - Naming preparation phase - (Pricing) to determine the price of the product and follow its procedures, whether accepted or rejected. - Processing (product prospectus and the degree of stability of the product) for Pharmacology - The stage of determining the stability of the product to get the approval of the stability - Preparation the final registry file to Meets with all the procedures and requirements for determining the date of approval & get notified Date or registry no. 11.prepare all the documents Apply to the( Institute of Nutrition) which include: - Prepare contracts requirements (Prepare contracts requirements (factory license - health certificate - storage devices - GMB)
Knowledge and skills requirement
1- Computer skills (MS office application)
2- language (English) excellent 3- communication skills
Work condition
Working conditions are normal for outside office environment
Physical demands
Limited to those normally associated with clerical jobs (sitting –standing