| Job Title: | Regulatory Affairs Specialist |
| Location: | Al Kuwait, Kuwait |
| Job Type: | Full Time Employee |
| Category: | Medical, Healthcare, Nursing |
| Description: | Regulatory and PV SpecialistAs RA you will be responsible for:• New registrations, Variations and Renewal files preparation, coordination with agents for files submission and approvals.• Obtain and maintain marketing authorizations to all products.• Maintain packaging material and labelling up-to-date according to HQ / local authorities’ requests.• Submission of safety data.• Approval of promotional materials. As PV you will be responsible for:You will be responsible for the Pharmacovigilance (PV) system, including compliance with local PV requirements in Kuwait, you will prepare and submit the PV files for all products registration to local authorities, monitor and follow up with local authorities to ensure timely fulfilment of PV requirements. In addition to that you will be the contact point with regulatory authorities as a QPPV and for any inspection purposes.Last but not least you will be responsible for the reconciliation and quality check of adverse events with all stakeholders as applicable. |
| Qualifications: | |
| Education: | Bachelor's degree / higher diploma |
| Experience: | Min: 5 |
| Salary: | Unspecified |
| Contact: |
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