Mô tả công việc
- Check and evaluate the CTD dossier and legal documents for the registration of imported drugs as per current regulation/guideline
- Prepare administrative part and coordinate with manufacturer to collect all sufficient dossier for submission.
- Check, prepare and submit GMP file for GMP assessment
- Regularly update circulars and decrees related to drug registration.
- Keep track of product registration progress and supplement quickly and accurately all the queries received.
- Submit variation/supplement when required.
- Prepare renewal documents and submit before registration number expires.
- Carry out additional tasks as assigned by line manager
Yêu cầu công việc
JOB REQUIREMENTS
+At least 5-year experiences in drug registration.
+ English (speaking, writing). Priority is given to candidates with 4 listening, speaking, reading and writing skills
+ Dedicated, honest and progressive working attitude
+Prioritize candidate who are truly dedicated and have a long-term commitment
BENEFIT :
- Salary negotiable (discussed directly during interview);
- Salary, bonus and welfare regimes according to Company regulations;
- Consider periodic salary adjustments based on work efficiency and business results of the Company;
- 13th month salary
- Participate in the social insurance regime according to regulations.
- Company trip each year
- Opportunities for long-term employment, personal development and career advancement.
Workplace:
Add: 7th Floor P&T Building, 27-29 Pho Duc Chinh, Nguyen Thai Binh Ward, District 1 , HCMC
Work time : Monday to Friday (8:30 am -17:30pm). Saturday ( 8:30 am - 12:30pm )
Quyền lợi được hưởng
Thưởng
Lương tháng 13, thưởng / 13th month salary, bonus
Chăm sóc sức khoẻ
Chế độ BHXH đầy đủ theo quy định của Pháp Luật
Nghỉ phép có lương
Nghỉ phép năm, lễ tết theo quy định / Annual leave, holidays according to regulations