RA Manager, Drug Project and RI (Pharmaceuticals)

Location: Shanghai, China; onsite

Company

hirify.global develops vital organ therapies, digital solutions, and advanced services, with a longstanding focus on kidney care and dialysis.

What you will do

• Develop and execute regulatory strategies for complex local manufacturing and imported drug projects across assigned therapeutic areas.
• Document regulatory decisions, scientific justifications, risks, and mitigation plans.
• Represent or lead cross-functional project teams and align regulatory strategies with business objectives and deliverables.
• Coordinate internal and cross-functional communications at project level and engage with health authorities.
• Monitor regulatory requirements, assess compliance with external standards, conduct gap analyses, and develop remediation plans.
• Lead regulatory intelligence and regulation-shaping activities with internal and external stakeholders.

Requirements

• Bachelor’s degree or higher in a pharmaceutical-related discipline.
• At least 15 years of professional experience, including a minimum of 5 years in regulatory affairs within a multinational company.
• Strong regulatory and scientific knowledge.
• Experience managing complex projects and timelines in a matrix environment, with strong problem-solving skills.
• Ability to identify regulatory strategies and risks independently and ensure timely, high-quality delivery.
• Strong communication, presentation, interpersonal, coordination, and regulatory authority engagement skills.

Culture & Benefits

• Work focused on extending patient lives and expanding possibilities in vital organ therapies.
• Collaboration across local, global, cross-functional, and external stakeholder groups.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.