RA/ PV Manager - Công Ty Dược Phẩm Của Nhật Bản

Mô Tả Công Việc
* RA:
- Registration of new VISA (Market Authorization) in Vietnam13 items are under process of registration.
- Extension and Maintenance of VISA in Vietnam
- Variation process for each our pharmaceutical products.
- Supporting Sales tender document and process in Vietnam
- Acceleration of RA tasks above by discussion with Pharmaceutical Government Function like MoH and DAV on behalf of Company
- Tracking the amendment of some circulation especially circular 32, 15.
- Join and contribution of Japanese Pharmaceutical Association.
- Operation regarding exporting RA matters. Exporting countries are Cambodia Philippines and Japan. Obtaining CPP, legalization and accreditation by some authorities.
- Weekly Report of every progress to GD and parent Japanese company.
- Registration of the license of food for speciality foods.
- Supporting the update GMP and GSP license for our own factory.
- Management for 2 staff's task and performance as team leader.
- Maintenance of internal SOP regarding RA matter.
* PV:
- Continuously educate PV process to our sales staff in line with our group policy.
- In case some adverse effect happens, taking the responsibility for PV matter
General:
- Management/responsible for RAPV activities
- Monitor, analyze and report on political, legislative and regulatory changes that will impact current and future company
- Participate in cross-functional team meetings to ensure timely registration of products to support the Company
- Supports regulatory requests and relevant regulatory affairs matters of OPV in VN
- Develops networking with DAV, MoH.
- Go to business trip according to your boss & BOD suggestion
- Other requests by BOD