Regulatory Affairs Manager

REGARA; Las Vegas (NV); Presencial; USD 140.000 - 200.000; Jornada completa

Descripción de la vacante

REGARA in Las Vegas, NV seeks a Regulatory Manager for Asia to own regulatory coverage across Japan, China, Korea, Australia, and APAC. You will lead quality, training, and customer insights to guide product and market strategy, while shaping a high-performing Asia Specialist team.

The role focuses on defining standards, mentoring staff, and partnering with sales and product to advance Regara's regional credibility in a fast-growing AI/regulatory tech space.

Formación

• 6+ years in regulatory affairs with Asia expertise (PMDA/MHLW, NMPA, MFDS, TGA)
• Authoritative knowledge of Asia submission pathways across device/IVD and/or pharma/biotech
• Experience setting quality standards and mentoring teammates
• Strong cross-functional leadership and customer-facing communication

Responsabilidades

• Own the quality and defensibility of Regara's AI outputs for Asia regulatory pathways; set standards and QA process
• Lead training and QA of the platform on Asia frameworks (Japan, China, Korea, Australia, others)
• Develop and mentor Asia Regulatory Specialists; set goals and standards
• Own voice-of-customer for Asia; translate needs into product and go-to-market
• Support sales, marketing, and customer success with strategic deals and education
• Define and maintain Regara's Asia regulatory coverage roadmap with product and AI teams
• Monitor Asia regulatory change and keep platform and team current
• Represent Regara's Asia credibility externally with customers and industry forums
• Collaborate with CRO and regional managers to maintain global standards

Conocimientos

Regulatory leadership

Cross-functional leadership

Customer-facing communication

Mentoring others

Educación

Bachelor's in life science/engineering

Advanced degree a plus

Descripción del empleo

Department

Regulatory Affairs

Reports to

Chief Regulatory Officer (or Director/VP of Regulatory Affairs)

Manages

Regulatory Specialist(s), Asia

Location

Las Vegas, NV (8400 W Sunset #300) - fully in office

Type

Full-time, Exempt

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 CRO 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.