Job Details
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Job Description
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.
Job Requirements
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.
