Thông tin tuyển dụng đăng ký thuốc
- Công ty JW Pharmaceutical Corporation tuyển dụng nhân viên đăng ký thuốc làm việc tại khu vực HN.
- Hạn chót nộp HS: Ngày 1 tháng 3 năm 2017.
- Bạn nào quan tâm xin gửi CV theo địa chỉ:
Khuat Tuyet Na
Representative Office of JW Pharmaceutical Corporation in HCM city (Vietnam)
Room 901A, 47 Le Van Huu Street, Ngo Thi Nham Ward, Hai Ba Trung District, Hanoi, Vietnam
Tel: 84-4 627 83175
Mobile: 84-983 670344
Chi tiết thông tin tuyển dụng vui lòng xem Job Description:
|Job title||RA EXECUTIVE|
|Reports to||RA manager|
Representing JW Pharmaceutical Corporation in its external communications (DAV, VFA, etc), representing local RA in communication with global team, preparing required documents in term of regulatory affairs.
Duties and responsibilities
1./ REGISTER DRUGS, FOOD SUPPLEMENTS, MEDICAL DEVICES, COSMETICS
Relating to submission of JW products:
- Contact global RA for admin. and technical registration dossier: Check the received documents as required by current regulation of drug registration and request additional documents for submission.
- Get artworks and PI, prepare Vietnamese label in line with current regulation on labeling.
- Request CIF price for registration.
- Translate/ Verify the translation PI and PIL
- Contact NOIP/ Agent in Vietnam to get trademark certificate.
- Complete registration dossier for submission.
Follow up (including preparation and submission of supplement /corrected documents required) for approval.
For changes need to be submitted for approval: Request required documents, prepare technical documents and forms, obtain signature and stamp on dossier, submit dossier and follow up till get approval.
Relating to SIQ submission:
- Prepare application form, technical documents, PI and artworks (including sub‐label), send dossier to importer for submission and follow up for approval.
- Co‐ordinate with local logistics/ local QA to make sure that the product imported into Vietnam in line with registration.
- Co‐ordinate with manufacturer if needed
Liaise closely with the regulatory authorities in DAV / VFA / NIDQC/ HUP / Department of Science and Education on a regular basis to ensure smooth and efficient registration process timely approval of new product registration, renewal, regulatory changes for company products in Vietnam
2./ Support business partners in relevant field of operation for achieving budgeted sales in trade in Vietnam.
3./ Provide input on regulatory requirements, update regulatory environment Supply document for QA, tender & advertisement purpose.
4./ Archiving and report on atimely manner
5./ Perform other tasks relating to RA activities assigned by direct manager.
- Graduated from pharmaceutical university
- Experience working as RA executive
- Good English skills
- Good office computer skills