Senior Manager / Associate Director - RegOps (Pharmaceutical)

TL;DR

Senior Manager / Associate Director - RegOps (Pharmaceutical): Leading the Japan-based regulatory operations team in managing complex global eCTD submissions and regulatory information systems with an accent on compliance, quality, and cross-functional stakeholder management. Focus on bridging Japanese and English-speaking teams, implementing regulatory technology, and developing team bench strength to ensure seamless business continuity.

Location: Must be based in Japan (Remote)

Company

hirify.global is a global strategic partner providing scientific services, medical communications, and learning solutions for the life sciences industry.

What you will do

• Own end-to-end eCTD publishing, submission management, and document control for major global regulatory filings.
• Administer and improve global regulatory information management systems to support Japan-based clients.
• Lead, coach, and develop a team of regulatory operations professionals.
• Partner with cross-functional stakeholders and clients to align on priorities, timelines, and risk.
• Support the implementation and configuration of regulatory technology platforms like Veeva Vault and docuBridge.
• Facilitate bilingual communication between Japanese- and English-speaking stakeholders.

Requirements

• 10+ years of experience in the pharmaceutical industry with a focus on Regulatory Operations.
• 5–10 years of people management experience.
• 5+ years of experience with eCTD publishing and managing major regulatory submissions.
• Fluent in Japanese and English.
• Experience with regulatory technology such as Documentum, Veeva Vault, or docuBridge.
• Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field.

Culture & Benefits

• Comprehensive benefits and wellness programs.
• Generous paid time off and flexible work arrangements.
• Performance-driven environment with professional development opportunities.
• People-first culture focused on diversity, inclusion, and growth.
• Regular team celebrations and community support initiatives.