Regulatory Support Excellence – Senior Associate (Pharmaceutical Regulatory Operations)

Location: Tokyo, Japan

Company

hirify.global is a biotechnology company developing and delivering medicines.

What you will do

• Execute standardized regulatory operational processes across submissions, reviews, and post-approval activities.
• Coordinate daily tasks with Regulatory Assistants and review their outputs for completeness, accuracy, and adherence to standards.
• Support the implementation and consistent application of SOPs, operational standards, and RACI across regulatory activities.
• Plan, prioritize, and track workloads, addressing delays, quality issues, and resource constraints.
• Coordinate regulatory document formatting and review documents against templates, formatting rules, and submission requirements.
• Operate regulatory systems such as RIM, maintain accurate data, and support meeting materials, minutes, and action tracking.

Requirements

• Bachelor’s degree.
• 3–5 years of experience in regulatory affairs, regulatory operations, or related pharmaceutical functions.
• Solid understanding of regulatory operations and document management.
• Strong attention to detail, execution discipline, and ability to manage multiple tasks and timelines concurrently.
• Clear and professional communication skills in Japanese and English.
• Collaborative mindset with a strong sense of accountability.

Nice to have

• Experience supporting regulatory submissions or regulatory lifecycle management.
• Hands-on experience with regulatory systems such as RIM.

Culture & Benefits

• Collaborative work with internal stakeholders and Regulatory Assistants.
• Focus on consistent, high-quality, and efficient regulatory execution.
• Work guided by defined processes, operational standards, and governance practices.