Senior / Regulatory Affairs Executive Asia Regional Access & Registration

Summary

We are seeking a highly motivated, adaptable, and detail-oriented Regulatory Affairs Executive / Senior Executive to join our team. In this role, you will lead and execute market entry and regulatory registration strategies across Southeast Asia for a diverse product portfolio, including Innovative Drugs, Generics, Traditional Chinese Medicine (TCM), and Medical Devices (including AI Medical Solutions).

You will work closely with health authorities across ASEAN markets, internal cross-functional teams, and external partners to ensure smooth, compliant, and timely marketing authorizations. We strongly value continuous learning and technical curiosity-if you are passionate about evolving regulatory landscapes (e.g., AI in healthcare, cross-border registration frameworks) and quick to master new product domains, we welcome you to join us!

Here, you will also have the unique opportunity to learn from and work directly alongside former HSA regulatory experts.

Key Responsibilities

1. Multi-Category Regulatory Strategy: Develop and execute tailored regulatory submission strategies for Innovative Drugs, Generics, TCM, and AI-driven/Traditional Medical Devices across various Southeast Asian countries.
2. Regional Submission Management: Prepare, review, and manage dossier submissions to key regional health authorities, including HSA (Singapore), NPRA (Malaysia), BPOM (Indonesia), Thai FDA, and other ASEAN regulatory bodies.
3. Compliance & Lifecycle Maintenance: Ensure full compliance with local and international regulatory standards, ICH guidelines, and ASEAN Common Technical Dossiers (ACTD/CSDT). Manage post-approval changes and license renewals.
4. Agency & Partner Liaison: Act as a key contact point for regulatory agencies and local distribution partners, efficiently handling authority queries and technical clarifications.
5. Cross-Functional Collaboration: Partner with R&D, QA, Commercial, and AI/Tech teams to ensure end-to-end regulatory compliance across product lifecycles.
6. Regulatory Intelligence & AI Integration: Track changing ASEAN regulations and emerging frameworks (such as AI medical software regulations and TCM registration pathways), translating insights into actionable guidance for business decision-making.

Requirements & Qualifications

Education

Bachelor's degree or above in Pharmacy, Life Sciences, Biomedical Engineering, or a related discipline.

Experience & Growth Mindset

3+ years of progressive experience in Regulatory Affairs within the Pharmaceutical, TCM, or Medical Device industries.

Flexible Experience Exemption: We value potential, adaptability, and a strong learning drive. Candidates with slightly less formal tenure but possessing outstanding learning agility, a proactive mindset, and a strong desire to master cross-disciplinary regulatory domains (e.g., MedTech, AI, or regional ASEAN entry) will be given strong consideration.

Knowledge & Skills

Solid understanding of ASEAN regulatory frameworks, ACTD/CSDT dossier formats, and international quality guidelines.

Exposure to multi-category registrations (e.g., medical devices, software as a medical device [SaMD], or TCM) is a strong plus.

Strong project management, cross-cultural communication, and problem-solving skills.

High attention to detail with the ability to manage multiple regional projects in a fast-paced environment.