Regulatory Affairs Supervisor
Full Time
Publishing date :10/12/2019
Experience :3 Years
Employee : Any
Location : Giza - Hadaik El Ahram, Al Haram.
Job Announcement
Seeking a Featured job, Bin Zayed Group announces its need for the following careers:
Regulatory Affairs Supervisor
Required to fulfill the following:
1- Responsibilities:
Preparation of the regulatory documents required for submission of the annual / complementary Importation Licenses and or importation approvals of FRANCO Products and working closely with the DRA / GRA team to ensure that the documents are valid and complete at the time of submission (CPPs, registration licenses, pricing certificates, variations approvals, etc.)
Working with different internal stakeholders in order to receive the documents required for issuing special import licenses for non-registered products (SILs) on timely manner.
2- Submission:
Filling in all MOH forms and templates required for submission.
Submission of the importation plans / approvals together with all the related documents to the concerned departments at MOH (Registration department licensing department importation department).
Submission of SILs requests to MOH.
Following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders
3- Inspection & Release Follow:
Follow up on inspection and release visit.
Follow up on the release tracker and sample conformity reports tracker.
Working closely with supply chain and Department of regulatory Affairs (DRA) release colleagues and providing support to ensure final release / inspection of the upcoming shipments are done on timely manner.
Follow up on Health Authority communication in terms of Drug shortage as well as inspection visits schedule.
Follow up on reference standards tracker tool.
4- Others:
Perform other duties as assigned.
5- Skills:
Bachelor of Pharmaceutical Sciences or Science Degree.
Minimum 4 years of experience within pharmaceutical industry Experience in regulatory/ importation processes and/or inspection & release of medicinal products.
Experience in different types of interaction with regulatory authorities Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
Negotiation & Communication Skills.
Leadership skills.
Strong interpersonal skills.
Good Command of English Language.
Computer Skills.
Full Time.
Complying candidates should send their C.V to the underlying
Seeking a Featured job, Bin Zayed Group announces its need for the following careers:
Regulatory Affairs Supervisor
Required to fulfill the following:
1- Responsibilities:
Preparation of the regulatory documents required for submission of the annual / complementary Importation Licenses and or importation approvals of FRANCO Products and working closely with the DRA / GRA team to ensure that the documents are valid and complete at the time of submission (CPPs, registration licenses, pricing certificates, variations approvals, etc.)
Working with different internal stakeholders in order to receive the documents required for issuing special import licenses for non-registered products (SILs) on timely manner.
2- Submission:
Filling in all MOH forms and templates required for submission.
Submission of the importation plans / approvals together with all the related documents to the concerned departments at MOH (Registration department licensing department importation department).
Submission of SILs requests to MOH.
Following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders
3- Inspection & Release Follow:
Follow up on inspection and release visit.
Follow up on the release tracker and sample conformity reports tracker.
Working closely with supply chain and Department of regulatory Affairs (DRA) release colleagues and providing support to ensure final release / inspection of the upcoming shipments are done on timely manner.
Follow up on Health Authority communication in terms of Drug shortage as well as inspection visits schedule.
Follow up on reference standards tracker tool.
4- Others:
Perform other duties as assigned.
5- Skills:
Bachelor of Pharmaceutical Sciences or Science Degree.
Minimum 4 years of experience within pharmaceutical industry Experience in regulatory/ importation processes and/or inspection & release of medicinal products.
Experience in different types of interaction with regulatory authorities Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
Negotiation & Communication Skills.
Leadership skills.
Strong interpersonal skills.
Good Command of English Language.
Computer Skills.
Full Time.
Complying candidates should send their C.V to the underlying
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