Regulatory Affairs Executive

Bạn Sẽ Làm Gì

The job will prepare all applications for the permits, license, certificates, authorization of the organization's products to conduct its business activities. The role will ensure the company regulatory affairs comply with statutory requirements.
To provide 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.
• Requesting of label, IFU, samples, test reports, raw data and relevant materials from production, sales, SCM.
• Coordinate registration orders for 3rd party manufacturers (if any)
• Update relevant depts as well as Regional/Global RA for newest updated concerned legal requirements.
• Provide administrative support within the functional scope.
• Approach GRA to be updated all RA issues within the organization

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

• Bachelor's Degree with 5 years of related working experience or Master's degree with 1 year of related working experience.
• Good at English both verbal and written.
• Strong verbal and interpersonal skills
• Customer-service oriented
• Self-motivated, requires little direction
• Able to work on multiple priorities simultaneously
• Able to follow directions and pay attention to details and deadlines
• Proficient in Microsoft Office Software