RAQA Senior Specialist – Southeast Asia

About the role

The RAQA Senior Specialist will lead regulatory approvals and quality management for products across Southeast Asia, ensuring timely market entry and compliance with both global and local requirements.

Key responsibilities

• Obtain and maintain product registration approvals in SEA countries in line with launch strategies.
• Develop regulatory strategies, submit pre‑market dossiers, and manage license renewals.
• Monitor evolving SEA regulations, assess impact, and communicate changes to internal and external stakeholders.
• Act as the management representative for QMS implementation, aligning corporate global QMS with local standards.
• Lead CAPA, non‑conformance, change control, and deviation investigations, driving continuous improvement.
• Coordinate complaints, adverse event reporting, product recalls, and field safety notices.
• Oversee qualification, monitoring, and periodic audits of distributors and third‑party logistics providers.
• Collaborate with global RA, labeling, and marketing teams to ensure compliant product labeling and promotional materials.

Required profile

• Proven experience in regulatory affairs and quality assurance within the SEA region.
• Strong knowledge of local health authority requirements and global QMS standards.
• Ability to interact effectively with internal teams, health authorities, distributors, and consultants.
• Excellent analytical and communication skills to interpret and convey regulatory changes.

Required skills

What we offer

• Opportunity to influence product launch strategies across multiple SEA markets.
• Collaborative environment with global regulatory and quality teams.
• Professional growth in a dynamic, multinational setting.