Masrouji Group was established in the year 1959 in Jerusalem as a trade and import
company for Pharmaceuticals. This modest operation has grown over the years to
become one of the leading trading and investment corporations in Palestine and
the wider Middle East regions, and has been distinguished for its emphasis on
ethical business practices and an appreciation for opportunity.
Masrouji Group is seeking a highly qualified Regulatory Affairs Coordinator in
Duties and Responsibilities:
- 1. Manage theRegulatory Affairs activities associated to new products.
- 2. To decide on theproduct price to be submitted to the pricing committee in the Health Authoritiesdepending on the price certificates and the necessary calculation based on Health Authorities regulations.
- 3. Review the price lists in the event of change in the exchange rate.
- 4. Submit to the Health Authorities the price adjustment when required.
- 5. Prepare high quality registration applications and registration files to besubmitted to the Health Authorities and other countries.
- 6. Scheduling appointments with Drug directorate/registration department to submit the official and complete dossier to Health Authorities Follow up with the Health Authorities to know the technical committee decision to get approval on product registration.
- 7. Follow up the requirement of the department of import at the Health Authorities such as original invoices, certificates, and receipt and control samples.
- 8. Awareness and Follow up with the Health Authorities’ regarding Pharmacovigilance issues.
- 9. Follow up and coordinate any issues related to the Recall process for the pharmaceutical products.
- 10. Awareness of the procedures related to technical customer complaint and adverse event related to pharmaceutical products.
- 11. Where applicable, to get the Health Authorities’ permission to import transactions for non-registered products by submitting the required certificates and documents.
- 12. Follow up with the Health Authorities different sections mainly dangerous Drugs Section, Inspection section and Quality Control Laboratory.
- 13. Perform market survey study for competitor products prices registered in Palestine.
- 14. Manage the correspondences with the different companies and answer their inquiries.
- 15. Report on Emerging issues including laws.
- 16. Participate in coordination of training activities for all the department employees in order to improve the performance continuously.
Required Qualifications and Experience:
1. B. Sc. degree in pharmacy or Doctor of Pharmacy.
2. A minimum of one year experience in Regulatory Affairs or in similar fields.
3. Good organizational skills.
4. Have enough skill in computer usage.
5. Good command of Arabic and English language.
Interested candidates are kindly requested to send their CVs to the