- Review regulatory documentation and technical product information
- Provide regulatory support for portfolio of products
- Establish and update registration database in the company
- Update licenses and collect information on registration instructions and regulations
- Provide and complete forms need in registration
- Carry out all subsequent follow up and pricing negotiations necessary to obtain the approval
- Checking all import permits
- Communicate with regulatory bodies in DM & MOH to facilitate successful product launch.
- Establish healthy & effective relationship with all concerned personnel at DM.
- Update Logistic team on products for shipment.
- Ensure approval of import permits by DM.
- Follow up and update all existing registration dossiers & handling minor change variations that crop up from time to time
- Ongoing visits and intensive call to all concern people
- Timely accurate solutions to all complaints
- Prepare 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.
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Regulatory Affairs Officer - Dubai - United Arab Emirates - Arabian Ethicals
Description
Company 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 Everyday
Job Description
The 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 Responsibilities:
Complete registration formalities for Pharmaceutical, Veterinary and Medical
Complete forms and requests originating from government agencies (DM)
Maintain contact with regulatory authorities
Provide the Logistic teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
Deal with quality related questions and complaints
Perform Pharma co-vigilance activities
Qualifications
Bachelors Degree or Higher
Additional Information
Pharmacy background is preferred but not essential
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Student Affairs Officer
Canadian University Dubai- Dubai, United Arab Emirates
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Student Affairs Officer
Only for registered members Dubai
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Student Affairs Officer
Only for registered members Dubai
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Regulatory Affairs Officer
Only for registered members Dubai, Dubai
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Regulatory Affairs Officer
Only for registered members Dubai
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Regulatory Affairs Officer
Only for registered members Dubai
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Student Affairs Officer
Full time Only for registered members Dubai
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Regulatory Affairs Officer
Only for registered members Dubai
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Regulatory Affairs Officer
Full time Only for registered members Dubai
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Pharmacovigilance & Regulatory Affairs Officer
Only for registered members Dubai
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Human Resources Officer – Employee Relations Affairs
Only for registered members Dubai
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Head of Corporate Affairs
Only for registered members Dubai
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Government Affairs Manager
Only for registered members Dubai
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Head of
Only for registered members Dubai
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Government Affairs Executive
Only for registered members Dubai, Dubai
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Assistant Dean
Peergrowth Consultancy Co.- Dubai, United Arab Emirates
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General Manager
Only for registered members Dubai
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Account Director
Only for registered members Dubai, Dubai, United Arab Emirates
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Account Director
Burson- Dubai, Dubai, United Arab Emirates
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Gerneral services - hr&admin(2026F026)
Only for registered members Dubai