Job Requirements
Job benefits
Medical insurance
Cover preventive care at no cost to you; all offer generous coverage for prescription medications; and all provide the financial protection you need in the event of a major illness or injury
Team-building events
Build camaraderie and trust within the company
Career growth
Take your knowledge to the next level with our assistance program
Workstation assistance
Laptop or desktop? We don’t mind! As long as you’re happy with the tool to help you!
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Skills
Job description for Regulatory Affair Executive at Công ty TNHH Dược Phẩm Euro Healthcare Việt Nam
- Process all the new dossiers till submit to DAV within the timeline.
- To prepare and compile registration dossiers as per the specific country guidelines and submit them to regulatory authorities.
- To prepare, review and compile re-registration documents.
- To prepare & review /check artwork, pack insert, SmPC etc.
- To study Regulatory guidelines of assigned countries and to prepare a checklist / template for registration dossiers.
- To verify specification of excipients, active, finished product and packaging material and all required documents.
- Application, review, coordination, follow-up of legal documents COPP, FSC etc.
- Maintain Proper database w.r.t to master document dossier.
- To collect and verify all technical documents and information from various departments at the manufacturing site.
- Provide Regulatory support to various departments.
- Review follow-up and coordination for registration samples /WS and impurities required for analysis purpose.
- To reply to any queries raised by the respective regulatory authority, in a timely manner.
- To maintain and update Registration certificate /information in regulatory databases.
- Be open for Freshers
- Candidates with at least 6 months to 1 year experience in Pharma Regulatory Affairs will be preferred.
- Have knowledge of the field of drug registration to deal with unusual and common problems.
- Have knowledge of drug development, quality control, quality assurance (related to drug registration).
- Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information.
- Must be organized- timely, and with information/data.
- Fluent English skills: Communication, Reading, Writing and Translation.
- Salary Negotiable (Based on your experience) and Allowance.
- Opportunity to work in a professional and responsible environment.
- Other benefits of the Company such as training, working equipment.
- To participate in Social insurance, Health insurance and Unemployment insurance according to regulations.
- Full benefits as prescribed by Vietnamese Labor Law.
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