About the job
We are seeking a dedicated and knowledgeable Regulatory Affairs Officer to oversee the management and facilitation of registration processes for Pharmaceutical, Veterinary, and Medical products. The ideal candidate will cultivate strong relationships with regulatory authorities and collaborate closely with our Logistics teams to ensure timely regulatory approvals. The officer will also address quality-related inquiries and remain informed about regulatory developments that impact our business growth.
Key Responsibilities:
Registration Management:
- Complete all registration formalities for Pharmaceutical, Veterinary, and Medical products.
- Review and validate regulatory documentation and technical product information.
- Provide regulatory support for the product portfolio.
- Maintain and update the registration database.
- Gather information on registration instructions and regulations while updating licenses.
- Complete necessary forms for product registration.
Government Liaison:
- Address forms and requests from government agencies (DM).
- Conduct follow-ups and pricing negotiations to secure approvals.
- Verify all import permits.
Regulatory Authority Communication:
- Engage with regulatory bodies in DM & MOH to facilitate successful product launches.
- Establish and maintain effective relationships with personnel at DM.
Logistics Support:
- Provide necessary regulatory input to the Logistics team to ensure timely approvals for product shipments.
- Keep the Logistics team informed about products scheduled for shipment.
- Ensure import permits are approved by DM.
Quality Assurance:
- Address quality-related questions and complaints promptly.
- Update existing registration dossiers and handle minor variations as they arise.
- Conduct regular follow-ups with all relevant stakeholders.
- Deliver accurate and timely solutions to complaints.
Pharmacovigilance:
- Develop pharmacovigilance SOPs as required by our principals.
- Train staff according to established SOPs.
- Monitor any reported safety cases diligently.
- Provide necessary documentation to principals during pharmacovigilance audits.

