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