Mô tả công việc
Phúc lợi công việc
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Hoạt động team-building
Giúp bạn xây dựng tinh thần đoàn kết, văn hoá và tin cậy với công ty
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Sức khoẻ
Các dịch vụ cá nhân hỗ trợ bạn về mặt tinh thần và giảm stress
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Công tác phí
Hỗ trợ phí đi lại khi công tác
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Nghỉ phép
Bạn có thể nghỉ phép hoặc nghỉ ốm không giới hạn, miễn là quản lý trực tiếp chấp thuận thời gian nghỉ của bạn
Tin đăng này được quản lý bởi
Kỹ năng
Chi tiết công việc Regulatory Affair Executive tại 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.
An toàn khi tìm việc trên Glints
KHÔNG cung cấp thông tin ngân hàng hoặc thẻ tín dụng khi ứng tuyển. Nhà tuyển dụng KHÔNG bao giờ yêu cầu chi phí ứng tuyển hoặc phí đào tạo.
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