SEA Regional Regulatory Lead: Drive Submissions & Approvals

Argyll Scott; Singapore; On-site; SGD 180,000 - 280,000; Full time

Job summary

Argyll Scott seeks a Regulatory Lead to build dossiers and drive submissions across Southeast Asia from a Singapore hub. You will own registrations, pathway strategy, and post-approval activities, shaping how medicines reach patients in the region.

With 10+ years in regulatory affairs for prescription medicines, you will lead a small regional RA function and collaborate with local partners to file in Singapore, Malaysia, Thailand, and Vietnam. Mandarin is a strong plus for regional coordination.

Qualifications

• 10+ years in regulatory affairs for prescription medicines.
• Hands-on experience filing innovative products with HSA, plus at least one or two SEA markets.
• Several years in a regional or cluster RA role.
• Experience building dossiers yourself, proactive, solutions-first approach.
• Mandarin is a strong plus.
• Mid-sized pharma, biotech or partner-model experience is an advantage.

Responsibilities

• Lead new product registrations (NCE/NBE) with HSA Singapore as the benchmark for the region.
• Oversee filings in Malaysia, Thailand and Vietnam via local partners from Singapore hub.
• Define pathway strategy: priority, abridged, reliance routes, and pre-submission meetings.
• Manage post-approval work: variations, renewals and labeling.
• For the right candidate, lead a small regional RA team and influence asset selection.

Skills

Regulatory affairs

Dossier building

Leadership

Strategy & pathways

Mandarin (strong plus)

Job description

Argyll Scott seeks a Regulatory Lead to build dossiers and drive submissions across Southeast Asia from a Singapore hub. You will own registrations, pathway strategy, and post-approval activities, shaping how medicines reach patients in the region.

With 10+ years in regulatory affairs for prescription medicines, you will lead a small regional RA function and collaborate with local partners to file in Singapore, Malaysia, Thailand, and Vietnam. Mandarin is a strong plus for regional coordination.