Regulatory Affairs Officer

Job DescriptionArabian Ethicals, a member of the Ghobash Group, was formed in the early 1970’s as a pharmaceutical distributor. Over the years, it has expanded its core business to become one of the leading pharma distributors in the UAE, but also diversified into adjacent segments such as veterinary, nutrition, and consumer products. Today, Arabian Ethicals is the trusted partner of global brands such as Merck-Serono, Sandoz, Acino, Nuk, and many others. With offices and warehouses in Dubai and Abu Dhabi and a team of over 120 dedicated employees, Arabian Ethicals is distributing to all major pharmacies, hospitals, supermarkets and other retail outlets across the country. Making an impact in the daily lives of the people in UAE, Arabian Ethicals serves with passion and aims to deliver through positive advancements in the healthcare industry. Touching Lives EverydayKey ResponsibilitiesComplete registration formalities for Pharmaceutical, Veterinary and MedicalReview regulatory documentation and technical product informationProvide regulatory support for portfolio of productsEstablish and update registration database in the companyUpdate licenses and collect information on registration instructions and regulationsProvide and complete forms need in registrationComplete forms and requests originating from government agencies (DM)Carry out all subsequent follow up and pricing negotiations necessary to obtain the approvalChecking all import permitsMaintain contact with regulatory authoritiesCommunicate with regulatory bodies in DM & MOH to facilitate successful product launch.Establish healthy & effective relationship with all concerned personnel at DM.Provide the Logistic teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planningUpdate Logistic team on products for shipment.Ensure approval of import permits by DM.Deal with quality related questions and complaintsFollow up and update all existing registration dossiers & handling minor change variations that crop up from time to timeOngoing visits and intensive call to all concern peopleTimely accurate solutions to all complaintsPerform Pharma co-vigilance activitiesPrepare pharma co-vigilance SOPs as required by our principals.Train the company staff as per the SOPs.Follow up for any reported safety case.Providing required documentation to principals during occasional PV audits.QualificationsBachelors Degree or HigherAdditional InformationPharmacy background is preferred but not essential#J-18808-Ljbffr