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