Position Title: Global Regulatory Affairs Specialist
Job description
- Oversight of regulatory submissions for assigned projects/countries, which may include completion of submissions or notifications, as required.
- Independently interacts and builds partnerships with competent authorities.
- Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
- Providing advice and support to the project team for regulatory or technical aspects of the projects.
- Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
- Other duties as assigned.
Requirements
- Preferably Bachelor students or above. Knowledge in medical-related field will be a plus.
- Fluent in English is a must, in other languages will be an advantage. Candidates who can speak Chinese will be a big plus.
- Ability to manage multiple projects, set priorities to meet deadlines.
- Keen attention to details.
- Strong interpersonal skills, in written and oral.
- Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.
- Work location: 236/43/2 Điện Biên Phủ St, 17 Ward, Bình Thạnh District, Hồ Chí Minh City.
- Time: 8:00-17:00 Monday – Friday
- Salary: 9 – 13m VND
Benefit
- Bonus 13th salary and Performance bonus
- Insurance & Paid-leaves as required by Labor Law
- Professional, dynamic working environment
- Domestic and overseas training opportunities.
Deadline for application: April 30th, 2021
Contact window: Please send resume and cover letter to Ms. Vivian (vivian@qualtechs.com)