Biotech Regulatory and Stewardship Manager

  • Ha Noi, Vietnam
  • Full-Time
  • On-Site

Job Description:

Title: Biotech Regulatory and Stewardship Manager
Working Place: Hanoi
Working time: Mon - Fri |9:00 - 18:00
Salary: Negotiable 

The role holder will:
  • Lead the registration and regulatory approval process for biotech products in line with global and country strategies.
  • Prepare and submit regulatory dossiers to support timely product registration and commercialization.
  • Coordinate registration applications and approvals for biotech product importation and cultivation with government authorities.
  • Liaise with regulators and global teams to address regulatory inquiries and ensure successful product approvals.
  • Monitor regulatory changes and communicate updates, assessing their impact on product registration and compliance.
  • Build and maintain strong relationships with government agencies, industry associations, academic institutions, and other key stakeholders.
  • Support advocacy initiatives and contribute to the development of Vietnam's gene editing regulatory framework.
  • Ensure compliance with regulatory requirements and support product stewardship implementation activities.
  • Collaborate with regional and global Regulatory & Stewardship teams to achieve business and regulatory objectives.
Requirements:
  • Bachelor's or Master's degree in Biotechnology.
  • Based in Hanoi, Vietnam.
  • Minimum 4–6 years of experience in regulatory affairs or related technical disciplines, preferably within the biotechnology industry.
  • Good understanding of the regulatory framework for biotech products.
  • Ability to interpret regulatory requirements and prepare comprehensive regulatory dossiers.
  • Strong organizational and project management skills with the ability to meet deadlines.
  • Fast learner with the ability to work effectively in cross-functional and cross-cultural environments.
  • Good communication skills in both Vietnamese and English.
  • Strong scientific and technical report writing skills.
  • Proficient in Microsoft Office applications, including Word and Excel.
Benefits:
  • Contract sign with Talentnet (12 months)
  • 13th month salary
  • Full SHUI, probation 100% salary
  • Have opportunity to extend and convert within the company