Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Staff- Regulatory Affair
Company:  B.Braun Vietnam Co. Ltd.
Job Posting Location:  VN-Hanoi (170 La Thanh Street)
Functional Area:  Regulatory Affairs
Working Model:  Onsite
Requisition ID:  976

Purpose: This position is for doing registration and other relevant regulatory activities of INT products (HC) including medical device and pharma

Task and responsibility:

1. Update regulation/ internal process of local HA regarding registration activities

1.1) Cooperate with local marketing to get confirmation on registration needs and request required documents for registration

1.2) Assess dispatched documents, and prepare dossiers for submission

1.3) Submission of the registration dossier, follow up and submit supplement dossier if any to get approval

1.4) Request, prepare, submit, and follow up variation dossiers as change management 

2. Update regulation/ internal process of local HA regarding registration activities

2.1) Understand clearly all the current regulations regarding product registration including medical devices and biocides, and update and implement new regulations if any

2.2) Understand all internal processes of local HA (IMDA, DAV) regarding evaluation activities of registration. update and adapt timely

2.3) Update and share with the team and relevant department for implementation 

3. Cross-function support including tender support and collaboration with SCM for the importation of registered products

3.1) Provide and order required documents as per LSM request for tender

3.2) Coordinate with LSM, and SCM for the importation of registered products, and provide legal or technical documents to them for their process.

4. AW development

4.1) Do artwork development after getting approval for product registration for production

4.2) Do keep informing SCM of the progress of the AW development implementation timeline for placing orders and any changes if any

 

Requirements:

  • Pharmacist or Chemical bachelor, understanding regulatory and registration activities

  • Fresh graduates or less than 1 year of experience

  • Working experiences in Pharmaceutical/Medical companies are preferable

  • Good relationship with the authorities related to registration task is preferable

  • Good knowledge and understanding of concerned legal requirement related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration are preferable

  • Good at English both verbal and written.

  • Strong verbal and interpersonal skills

  • Customer-service oriented

  • Self-motivated, requires little direction

  • Careful, honest, high sense of responsibility

  • Able to work on multiple priorities simultaneously

  • Able to follow directions and pay attention to details and deadlines

  • Computer literacy, proficient in Microsoft Office Software
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