1. 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.
- Liaise and negotiate with regulatory authorities.
2. Keep up to date with changes in regulatory legislation to ensure compliance of the company.
3. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- 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.
4. Develop regulatory strategies and implementation plans for the preparation and submission of new products.
5. Advising and providing mandatory information related to the import of goods into the VN market.
6. Follow up and resolve issues related to delivered products. Take necessary actions (submit renewal, change) to ensure products can be circulated continuously.
More detailed job deion to be discussed and given on your joining.
Mô tả công việc
Yêu cầu công việc
- More than 2 years experience in Pharma Regulatory Affairs.
- In-depth knowledge of drug registration: Full understanding of the field of drug registration to deal with unusual and common problems.
- Full 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.
- In-depth knowledge of drug registration: Full understanding of the field of drug registration to deal with unusual and common problems.
- Full 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.
Quyền lợi được hưởng
- 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.
- 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.
Hồ sơ bao gồm
CV by English
Thông tin liên hệ
- Người liên hệ: Công ty TNHH Dược Phẩm Euro Healthcare Việt Nam
- Địa chỉ: 6 Phùng Khắc Khoan, phường Đa Kao, Quận 1
- Email: Đăng nhập để xem email
- SĐT: Đăng nhập để xem SĐT