Regulatory Affairs Specialist - Glaxan Pharma

About the Job

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 a 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 the inspection and release visit.
• Follow up on the release tracker and sample conformity reports tracker.
• Working closely with the 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 a timely manner.
• Follow up on Health Authority communication in terms of Drug shortage as well as inspection visits schedule.
• Follow up on the reference standards tracker tool.

4- Others

• Perform other duties as assigned.

Job Requirements

Skills:

• Bachelor of Pharmaceutical Sciences or Science Degree.
• Minimum 2 years of experience within the 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.

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