Regulatory Affair

- 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

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 )