[Hanoi] - Urgent - Regulatory Affairs Manager (Pharmaceutical Products) ($3000-$3500)

NavigosSearch&039;s client is a FDI company looking for a position of RA-PV Manager with detail tasks as below:
- Supports regulatory requests and relevant regulatory affairs matters of company in VN
- Management/responsible for RAPV activities
- Develops networking with DAV, MoH.
- Other requests by BOD
- Go to business trip according to your boss & BOD suggestion
- Participate in cross-functional team meetings to ensure timely registration of products to support the Company
- Monitor, analyze and report on political, legislative and regulatory changes that will impact current and future company
* About RA:
- Management for 2 staff’s task and performance as team leader.
- Variation process for each our pharmaceutical products.
- Supporting Sales tender document and process in Vietnam
- Tracking the amendment of some circulation especially circular 32, 15.
- Maintenance of internal SOP regarding RA matter.
- Registration of the license of food for speciality foods.
- Weekly Report of every progress to GD and parent Japanese company.
- Acceleration of RA tasks above by discussion with Pharmaceutical Government Function like MoH and DAV on behalf of Company
- Operation regarding exporting RA matters. Exporting countries are Cambodia Philippines and Japan. Obtaining CPP, legalization and accreditation by some authorities.
- Extension and Maintenance of VISA in Vietnam
- Supporting the update GMP and GSP license for our own factory.
- Registration of new VISA (Market Authorization) in Vietnam 13 items are under process of registration.
- Join and contribution of Japanese Pharmaceutical Association.
*About PV:
- In case some adverse effect happens, taking the responsibility for PV matter
- Continuously educate PV process to our sales staff in line with our group policy.

- Fluent at English
- High responsibility in work
- Male/Femal graduated from Universtiy
- Experience of being a pharmacist, experience for 5 year or more as RA/PV manager. If the candidates have the work experience in DAV or MOH, that could be advantageous.

Competitive remuneration package

Social and Heath Insurance

International and professional work environment

Cập nhật gần nhất lúc: 2021-12-29 12:32:02