Regulatory Affair Staff_Medicine (Nhân Viên Đăng Kí Thuốc)

- Monitor the registration status of products in DAV.
- Coordinate with manufacturers and prepare dossiers for medicine product registration (Renewal registration, variation registration, new registration) or product import quota and submission to Regulatory authorities (DAV).
- Follow to get the approval of marketing authorization, import quota, variations in
timely manner.
- Support Business team in applying for advertisement licenses & detail aid material printing permits.
- Develop artwork required for packaging to secure new product launching and secure stock for sales.
- Supply the required information/documents for requirements of external or internal colleagues including Health Authorities (Ministry of Health) to conform to Company’s regulations and law.
- Coordinate with Business team to support for product’s availability on market.
- Promotional material registration:
- Other duties: Hospital tender supports: provide documents (GMP, CoA, CPP,..), official letter (explanation/commitment,.) to support hospital tender application.
- Prepare reports required by Regulatory Affairs Director.
- Review promotional material, and support Marketing to revise in accordance with DAV’s requirements.
- Submit dossier in time and follow up on the submission process.
- Review product information published on MIMS/VIDAL
- Other tasks are assigned by Regulatory Affairs Director.

- Good MS office skills (Word, Excel, PowerPoint, Corel/AI)
- Medical/ Pharmaceutical University graduated
- 1 Female/Male
- Good communication & office administrative skills
- Understanding of regulatory rules and regulations of the Ministry of Health
- At least 1 or 2-year experience at the same position.
- Good English skills.

- Enjoy quarterly productivity and periodic salary increases
- Dynamic and friendly working environment. Have the opportunity to work with many big and reputable partners.
- To enjoy full benefits of employees according to current law (Social Insurance, Health Insurance).
- Opportunities for personal development and advancement in the organization.
- Negotiate salary based on candidate&039;s experience and skills
- Enjoy the mode of travel with the Team, Tet holiday bonus, bonus according to the Company&039;s business sales.
- Participated in advanced training in depth, expertise and soft skills.

Cập nhật gần nhất lúc: 2022-06-03 10:22:04