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 regulatory registration strategy and execution for biotech products in Vietnam.
  • Prepare and submit regulatory dossiers to support timely product registration in line with business priorities.
  • Coordinate registration applications for biotech product importation and cultivation with relevant government authorities.
  • Engage with regulators and global teams to address regulatory inquiries and facilitate product approvals.
  • Monitor and communicate regulatory updates and assess their impact on biotech product registration.
  • Build and maintain 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 applicable regulatory requirements and support product stewardship activities.
  • Collaborate with regional and global Regulatory & Stewardship teams to achieve business and regulatory objectives.
Requirements:
  • Bachelor's or Master's degree in Biotechnology or a related discipline.
  • Minimum 4–6 years of experience in regulatory affairs or a related technical field, preferably within the biotechnology industry.
  • Strong understanding of the regulatory framework governing biotech products in Vietnam.
  • Ability to interpret regulatory requirements and prepare comprehensive regulatory dossiers.
  • Strong project management and organizational skills with the ability to manage multiple priorities.
  • Fast learner with the ability to work effectively in cross-functional and cross-cultural environments.
  • Excellent 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
  • 13th month salary
  • Annual medical checkup + Medical insurance
  • Full SHUI, probation 100% salary
  • Have opportunity to extend and convert within the company