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Regulatory Affairs Officer

On-site Full-time

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Experience Level

Experience

Qualifications

Bachelor's Degree or higher in a relevant field.

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.

About Arabian Ethicals

Arabian Ethicals, a proud member of the Ghobash Group, has established itself as a leading pharmaceutical distributor since the early 1970s. Over the years, we have expanded our core business into diverse segments including veterinary products, nutrition, and consumer goods. We proudly partner with renowned global brands such as Merck-Serono, Sandoz, and Acino, among others. With strategically located offices and warehouses in Dubai and Abu Dhabi, and a dedicated team of over 120 professionals, we are committed to delivering healthcare solutions that positively impact the lives of people across the UAE. Arabian Ethicals is dedicated to making a difference every day in the healthcare industry.

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