Regulatory Affairs Officer

🏢 Arabian Ethicals
📍 United Arab EmiratesFull-timeOn-site
📅 Posted: 3w ago🔄 Updated: 3w ago
CV%
✨ AI Summary
Arabian Ethicals is seeking a Regulatory Affairs Officer to manage and facilitate registrations for Pharmaceutical, Veterinary, and Medical products. The role involves building relationships with regulatory authorities, coordinating with logistics for timely approvals, and handling quality-related queries. The ideal candidate will stay updated on regulatory aspects pertinent to business development and ensure timely completion of registration formalities and updates. Key responsibilities include reviewing regulatory documentation, providing regulatory support for the product portfolio, maintaining registration databases, and updating licenses. The officer will also be responsible for obtaining import permits, communicating with regulatory bodies like DM & MOH, and managing quality-related complaints. Pharma co-vigilance activities and training company staff on SOPs are also part of the role.
Required Skills
Other
import permitsregulatory documentationPharma co-vigilanceregulatory support
Requirements
The role requires a Bachelor's Degree or higher, with a preference for a Pharmacy background. Key responsibilities include managing pharmaceutical, veterinary, and medical registrations, building relationships with regulatory authorities, providing regulatory input for timely approvals, handling quality-related queries, and staying updated on regulatory aspects. The job holder will also be responsible for maintaining registration databases, updating licenses, and ensuring the approval of import permits.
Description
Arabian 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 EverydayJob DescriptionThe job holder is responsible for management and facilitation of registration related to Pharmaceutical, Veterinary and Medical. She/he builds relationship with regulatory authorities; coordinates with Logistic teams to provide regulatory input in order to obtain timely regulatory approvals for the products; handles quality related queries / complaints; and stays updated on regulatory aspects pertinent to business development.Key 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
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🎯 Overalli74%
⚡ Skillsi85%
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Ontology Match: 85.0
Matched:✓ Requirements Matching✓ Ontology Skills Mapping
📜 Eligibilityi49%
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Local: 19600%
🏗️ Career Fiti91%
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Seniority: 91.0
📋 Requirementsi67%
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Domain: 67.0
🔥 Motivationi78%
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Title Fit: 78.00