Regulatory Affair

Công ty TNHH JAC Recruitment Việt Nam

Mức lương: 44 - 56 triệu Kinh nghiệm: 5 năm Nơi làm việc: Hà Nội

Trình độ: Đại học Đã hết hạn

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Nộp đơn Lưu việc làm

Mô tả công việc

*Review the stability and manufacturing data available in the Investigational Medicinal Product Dossier
*Review the checklist of the documents required for the submission.
*Review all the documents sent by the client as per the checklist sent to the sponsor.
*Prepare and Review of the complete regulatory dossier for submission.
*Make Regular visits to the regulatory offices to get an update of the approval status and follow-up of the application.
*Escalate any query generated by the regulatory office to the Incharge (Regulatory)
*Receive the query generated by the regulatory office and send the scanned copy to the Incharge.
*Review the reply sent by the sponsor in the regulatory office.
*Review the Approval letter for correctness

Yêu cầu công việc

UST:
1/ Have experience of RA & PV in pharmaceutical industry over 5 years as Manager level
2/ Understood DAV’s requisition on documents of drug registration, renewal, change packing size, GMP,…
3/ Have good relationship with DAV/MOH, which could support to RA’s activities
4/ Could set up action plan and manage timetable for approval of authority
5/ Could set up expenses budget for RA activities and control well
6/ Be Pharmacist or Doctor
7/ Good English in write and talk
8/ Ready for business trip
WANT for priority:
1/ Have working experience in local factory with oversea capital.
2/ Have good knowledge about MOH/DAV activities and their organization
3/ Have wide friend network on field
4/ Have good ability to convince partners and working in team
5/ Would like to work for long time

Phúc lợi công việc

Follow labor rules, and more: party, sport activity, salary review, annual team building...
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