Regulatory Manager — Asia

Position summary

This is not a traditional regulatory affairs role — the Regulatory Manager for Asia does not prepare or file Regara's own submissions. The role is the senior regional authority who owns Regara's regulatory coverage and credibility for Asia across three roughly equal pillars: leading training and QA of the AI on Japan, China, South Korea, Australia, and broader APAC frameworks, owning voice-of-customer for the region, and serving as senior content expert for go-to-market. The Manager sets the regional quality standard and develops the Asia Specialist team.

Key responsibilities

• Own the quality and defensibility of Regara's AI outputs for Asia regulatory pathways — setting the standard and the QA process.
• Lead training and QA of the platform on Asia frameworks (PMDA and MHLW (Japan), NMPA (China), MFDS (South Korea), TGA (Australia), and other Asia-Pacific authorities), prioritizing what the AI must get right.
• Manage and develop the Regulatory Specialist(s) for Asia; set goals and standards.
• Own voice-of-customer for Asia, synthesizing regional RA needs into product and go-to-market.
• Serve as senior Asia content expert supporting sales, marketing, and customer success (strategic deals, thought leadership, education).
• Define and maintain Regara's Asia regulatory coverage roadmap with the product and AI teams.
• Monitor and interpret Asia regulatory change; keep the platform and team current.
• Represent Regara's Asia credibility externally with customers and at industry forums.
• Partner with the Director of Regulatory and peer regional managers to keep standards consistent globally.

Qualifications

Required

• 6+ years in regulatory affairs with deep Asia expertise (PMDA and MHLW (Japan), NMPA (China), MFDS (South Korea), TGA (Australia), and other Asia-Pacific authorities), including senior or lead responsibility.
• Authoritative knowledge of Asia submission pathways across device/IVD and/or pharma/biotech.
• Experience setting quality standards and, ideally, managing or mentoring others.
• Strong cross-functional leadership and customer-facing communication.
• Ability to work fully in office in Las Vegas.
• Bachelor's in a life science, engineering, or related field; advanced degree a plus.

Preferred

• Asia regulatory certification and/or proficiency in an Asian language such as Japanese, Mandarin, or Korean.
• Experience across multiple Asia markets and product types.
• Experience in regulatory technology, consulting, or a software/AI environment.

What success looks like

Within the first year, Regara's Asia regulatory coverage meets a defined quality bar, the Asia specialist team is productive and developing, regional customers' needs shape the product, and Regara is credible in the Asia market.