Zahrawi Group is a leading company in the GCC Healthcare Industry with its
presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and
distributes high-quality products and services to Hospitals, Clinics,
Laboratories, & Analytical Industries.
Responsible for all Product Classification/Manufacturing Site Registration and
Product Registration and to ensure that all documents required are available
and are submitted on time. They are also responsible for the preparation of
the pre- and final perm
Policies & Procedures:
* Adhere to all Zahrawi Policies & Procedures as applicable.
Regulatory Affairs:
* Ensure that Zahrawi's products comply with the regulations of the MOH.
* Keep up to date with the latest changes in regulatory legislation and guidelines.
* Liaise and negotiate with regulatory authority to ensure a smooth registration process.
Product Classification & Registration:
* Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
* Prepare all required documents to be submitted for Product Classification under MOH.
* Prepare all required documents to be submitted for Manufacturing Site registration under MOH.
Importation Permits:
* Prepare and apply for the pre-permit document as per the MOH guidelines and verify the items being imported and the documents required.
* Communicate with the existing and new suppliers regarding MOH importation rules and policies.
* Upload on the MOH importation system any new classifications or registration certificates.
Audit:
* Prepare any documentation needed for internal and external audits.
* File all documents in the corresponding files to ensure all are available and are correct.
* Evaluate the suggestions after the audit and implement them when possible.
Pharmacovigilance System:
* Responsible for Pharmacovigilance related work and assigned as deputy QPPV.
* Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer's comments.
* Conduct monthly PV activities to keep full compliance with the regulations.
* Prepare and review all SOP's Pharmacovigilance plans for all Zahrawi Suppliers.
Medical Devices FSN/FSA Vigilance system:
* Report the received FSN/FSA to the health Authority and keep align with the reporting timelines.
* Keep tracking for the reported cases and the health Authority requirements to ensure fulfillment.
* Keep updated with the new regulations related to the local vigilance system and report them to the manager
REQUIREMENTS
* Education: Bachelors Degree
* Additional details:
* Candidates must be based in the UAE and should be willing to move to company visa
* Candidates must have a valid MOH license
* Experience: 2 - 4 years of experience.
* Job Specific Skills: Require a good knowledge in Pharmacist, Regulatory Affairs, Importation Permits
Location: UAE - Dubai
Job Type: FULLTIME
Job Posting Date: 16-11-2023
Division/Department: Warehouse Operation and Distribution
**Regulatory Affairs Executive** **-** **233533** ** THE POSITION** Do you have MAH (Marketing Authorization Holder) registration experience? Do you have product life maintenance (variation, leaflet update, renewals) experience in regulatory affairs? Are you familiar with SFDA portals/systems? W…
**Regulatory Affairs Executive - CD &O** **-** **230903** ** Regulatory Affairs Executive CD &O -** **ID: 230903** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer …
###### **About Zahrawi Group** Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries. #####…
Develops and ensures implementation of regional RA strategy for sanofi-aventis products. Serves as focal point between Affiliate RA and other RA functions. Responsibility of various countries or various registered products. Ensures the maintenance of the A.M.M.: renewals, variations, answers …
**Regulatory Affairs Intern** **-** **231227** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,0…
769 million lives touched by our products. Imagine what you could do at Novartis. No matter where you work, you could contribute to solving some of the toughest healthcare challenges and have an extraordinary impact on people's lives. Join us! We are looking for a Regulatory Affairs Associate …
## **Job Summary** As Regulatory and Quality you are overall responsible for Product Stewardship and Regulatory Affairs in IFFCO Group. The incumbent is responsible for the regulatory approval of food products and labels as well as influencing regulations, legislation and industry protocols to the …
**POSITION SNAPSHOT** * Location: Dubai - UAE * Company: Nestle * Role: Regulatory and Scientific Affair Manager **POSITION SUMMARY** An exciting opportunity has arisen for a Regulatory Affairs Manager to join our business, this is a varied role that will works across the MENA region. I…
###### **About Zahrawi Group** Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries. #####…
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment…