Executive - Regulatory Affairs

Bạn Sẽ Làm Gì

This position is in charge of providing regulatory support in the registration of pharmaceutical and medical devices in B. Braun Vietnam. This includes to:

• Be responsible to apply and get needed Certificate/License for production/ Import/ Export of Products, GMP and Manufacturing
• Manage to ensure validity of all above certificates/licenses
• Proceed to apply authorities to get approval for change (if any) related to products/facilities under responsibilities
• Assist in requesting of label, IFU, samples, test reports and raw data from production
• Assist in preparation of Raw Material List for BBVVN manufactured pharmaceuticals
• Coordinate registration orders for 3rd party manufacturers (if any)
• Update relevant departments as well as Regional/Global RA for newest updated concerned legal requirements
• Provide administrative support within the functional scope

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Chuyên Môn Của Bạn

• Graduated from Universities. Majored in Pharmacy, Medical, Chemistry or Biology
• At least 1-year experience
• Fluency in English: Writing and speaking
• IT Skills: Words, Excel, Power Point
• High attention to details
• Be able to work both independently and teamwork
• High level of integrity with good ethical core values
• Deals well with ambiguity, proactive and a quick learner
• Effective communication, organization and planning