Regulatory and PV Specialist

As 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.

Job Details

Preferred Candidate

Prepare and submit all documents required for importation approvals, customs release and customs exemptions.Follow up and respond to all the health authorities’ inquiries in a timely manner until granting the final approvals.Responsible for handling all the health authorities visits (EDA & NFSA).Keep up-to-date with all health authorities’ new regulations.Support the marketing team in any inquiry related to the health authorities.Prepare the registration dossier for the company products.Keep track record for all the submitted documents and all the approvals.

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