About Us:
VOS Discovery, a biotech company pioneering the CRO market in Vietnam and a subsidiary of Organoid Sciences, is expanding its
expertise in regulatory affairs across multiple industries. Our work spans health functional foods, pharmaceuticals, and import/export
compliance, ensuring compliance with global regulatory standards. We are seeking a highly motivated Regulatory Affairs Specialist to
manage, coordinate, and ensure compliance with national and international regulatory requirements. The ideal candidate will have
experience in product registration, licensing, and regulatory submissions in biotech, healthcare, and related industries.
Responsibilities:
- Regulatory Compliance & Strategy:
- Develop and execute regulatory strategies to ensure compliance with health functional food, pharmaceutical, and import/export regulations.
- Keep up to date with evolving regulatory requirements in Vietnam and globally.
- Product Registration & Licensing:
- Manage the preparation and submission of regulatory applications for product approvals, renewals, and modifications.
- Work closely with regulatory agencies to ensure smooth approvals and compliance.
- Import & Export Compliance:
- Ensure adherence to regulatory and customs procedures for importing and exporting products.
- Liaise with customs authorities and regulatory bodies to resolve any compliance-related issues.
- Documentation & Dossier Preparation:
- Prepare and review regulatory documents, including dossiers, technical files, and quality reports.
- Ensure all submissions meet local and international guidelines.
- Cross-functional Collaboration:
- Work closely with R&D, production, legal, and marketing teams to align regulatory processes with business objectives.
- Provide guidance on regulatory matters to internal teams and stakeholders.
- Risk Management & Quality Assurance:
- Identify potential regulatory risks and develop mitigation strategies.
- Support quality assurance teams to ensure compliance with GMP, GLP, and other relevant industry standards.
- Government & Stakeholder Liaison:
- Maintain strong relationships with regulatory authorities, industry associations, and external consultants.
- Represent the company in regulatory discussions and policy updates.
Skills and Experience:
Must Have:
- 5+ years of experience in regulatory affairs, particularly in health functional foods, pharmaceuticals, and import/export regulations.
- Strong knowledge of national and international regulatory frameworks (e.g., FDA, EMA, ASEAN regulations, Vietnamese Ministry of Health).
- Experience in preparing, submitting, and managing regulatory applications and approvals.
- Ability to conduct patent searches, prior art analysis, and risk assessments.
- Understanding of customs procedures and compliance for import/export activities.
- Strong documentation and analytical skills for regulatory submissions.
- Fluent in English (written and spoken).
- A degree in pharmacy, biotechnology, regulatory affairs, or a related field.
Nice to Have:
- Experience in regulatory affairs for biotech and CRO-related products.
- Familiarity with clinical trial approvals and ethical compliance requirements.
- Prior experience working with government agencies and regulatory bodies.
- Strong negotiation skills for regulatory discussions and approvals.
- Additional certifications in regulatory affairs or quality assurance.
Why Join Us?
- Lead and shape regulatory strategies for an innovative and growing company.
- Full compliance with salary policies, insurance contributions, and benefits according to Vietnamese law.
- Work in a dynamic and fast-paced environment with global impact.
- Career development opportunities in biotech, healthcare, and regulatory fields.
- A collaborative and forward-thinking workplace where your expertise makes a real difference.
- Opportunities to work with international regulatory agencies and expand global market reach.
Join us and play a crucial role in ensuring regulatory compliance and advancing groundbreaking innovations. Apply today!