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.
Executive - Regulatory Affairs
Company:  B.Braun Vietnam Co. Ltd.
Job Posting Location:  Hanoi, Hà Nội, thủ đô, Vietnam
Functional Area:  Regulatory Affairs
Working Model:  Onsite
Requisition ID:  10934

About the Role

We are looking for an Executive – Regulatory Affairs (RA) to lead the RA sub-team for the HC portfolio (PAT products) and drive all regulatory activities for product registration, GMP assessment, and compliance with local health authority requirements. This role plays a key part in ensuring successful product registration, regulatory updates, cross-functional coordination, and quality support.

Key Responsibilities

1. Lead RA PAT Product Group (HC Portfolio)

  • Delegate tasks and manage the RA sub-team.
  • Coach and develop team members on regulatory activities related to their assigned products.
  • Support the RA Manager on team management tasks including strategic planning and budget control.

2. Product Registration & GMP Assessment (PAT–HC)

  • Work with Local Marketing to confirm registration needs and collect required documents.
  • Assess documents, prepare and submit registration dossiers.
  • Follow up on approvals and submit supplemental dossiers when required.
  • Coordinate and submit variation dossiers for change management.
  • Collaborate with local R&D to confirm registration requirements and gather documentation.

3. Regulatory & Internal Process Updates

  • Stay updated on all regulations related to medical device and drug registration.
  • Understand and follow internal processes of local HA (IMDA, DAV); implement updates timely.
  • Share regulatory updates with the RA team and relevant departments.

4. Cross-functional Support

  • Provide required documents for tender activities.
  • Coordinate with Sales & Marketing and SCM for importation of registered products.
  • Provide legal/technical documents for customs clearance and other processes.

5. Artwork (AW) Development

  • Develop artwork after receiving product registration approval.
  • Keep SCM informed of AW development timelines and any changes.

6. QA Coordination

  • Support QM and act as the single point of contact with local Health Authorities for all quality management procedures.

Key Working Relationships

Internal

  • Sales & Marketing: registration alignment, tender support.
  • SCM: ensure compliant importation of registered products.
  • QM: support quality-related procedures and tender activities.

External

  • Local importer/distributor: quota applications & related activities.
  • Health Authorities (IMDA, DAV): submission, follow‑up, regulatory updates.
  • Global/Inter-company RA: request/coordinate documents and global registration fees.

Qualifications

Education

Must have:

  • Pharmacist or related field

Experience

Must have:

  • Minimum 5 years’ experience in RA (pharma) and at least 2 years in an MNC
  • Strong relationship with DAV

Nice to have:

  • Experience in medical device RA

Key Skills

  • Fluency in English
  • Strong communication & presentation skills
  • Computer literacy (MS Word, Excel)
  • Logical thinking & analytical mindset
  • People management skills
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