Mô tả công việc
Process all the new dossiers till submit to DAV within the timeline.
Application, review, coordination, follow- up of legal documents COPP, FSC etc.
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.
To prepare, review and compile re- registration documents.
To prepare and compile registration dossiers as per the specific country guidelines and submit them to regulatory authorities.
Liaise and negotiate with regulatory authorities.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Keep up to date with changes in regulatory legislation to ensure compliance of the company.
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.
To maintain and update Registration certificate /information in regulatory databases.
Review follow- up and coordination for registration samples /WS and impurities required for analysis purpose.
Provide Regulatory support to various departments.
To reply to any queries raised by the respective regulatory authority, in a timely manner.
Follow up and resolve issues related to delivered products. Take necessary actions (submit renewal, change) to ensure products can be circulated continuously.
Advising and providing mandatory information related to the import of goods into the VN market.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
More detailed job description to be discussed and given on your joining.
Yêu cầu ứng viên
Fluent English skills: Communication, Reading, Writing and Translation.
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.
In- depth knowledge of drug registration: Full understanding of the field of drug registration to deal with unusual and common problems.
More than 2 years experience in Pharma Regulatory Affairs.
Please send CV by English
Quyền lợi
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.
