Regulatory Affairs Manager

2 weeks ago

Singapore GENE SOLUTIONS SGP PTE. LTD. Full time

Gene Solutions, a pioneer, rapidly growing and well-funded biotechnology company with cell-free DNA platform focusing on women’s health and oncology. We aim to transform the standard of healthcare in developing countries by making breakthrough genetic tests affordable and accessible to millions of people.

We have multiple openings for business development managers who will be working in South East Asian countries to serve our exponential growth..

**Job Summary**:
Lead and coordinate registration of international biotech certifications (CAP, FDA, HSA, NMPA, etc.) across APAC. Manage and collaborate with across relevant team/member to ensure timely and compliant registration.

**Key Responsibilities**:

- Develop and execute registration strategies for CAP, FDA, HSA, NMPA, and other international certifications within the APAC region.
- Manage end-to-end registration projects, including documentation, submission, and liaison with regulatory bodies.
- Be the primary contact person for the certificate registration, leading local certification processes and ensuring compliance with each country’s requirements.
- Work closely with local/international project team or on-site Regulatory leads to plan and align submission strategies.
- Coordinate with internal teams (Lab, QA, Operations, Legal, ) and external consultants for dossier preparation.
- Monitor regulatory changes, assess impact, and provide guidance for certification maintenance.
- Track project timelines and budgets; escalate deviations and propose mitigation plans.
- Provide progress updates and reports to senior management and stakeholders.

**Job Requirements**
- Bachelor’s degree in Biotechnology, Life Sciences, Pharmacy, or related field. Master’s preferred.
- 5+ years in biotech/pharma regulatory affairs, particularly with CAP/FDA/HSA/NMPA submissions in Asia.
- Proven track record in managing international certification projects and engaging with health authorities.
- In-depth knowledge of regulatory frameworks in at least one or two APAC countries.
- Excellent project management abilities, attention to detail, and organizational skills.
- Strong communication and collaboration skills across cross-functional teams and countries.
- Fluency in English. Additional regional languages (e.g., Mandarin) is a plus.

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