Associate Director, Regulatory Affairs, Post Approval (Biotech)

Location: Japan, with a hybrid work environment in the Tokyo office

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead maintenance of the Japanese Package Insert for approved products and support creation for sNDA submissions in collaboration with Global Regulatory Affairs Labeling.
• Provide regulatory leadership for manufacturing and marketing authorization licenses.
• Lead information disclosure requests and other post-approval regulatory activities.
• Review promotional, scientific, and medical communications for compliance with the PMD Act, JPMA Promotion, and applicable advertising regulations.
• Interpret evolving Japanese regulations and assess their impact on products and business operations.
• Partner with Medical Affairs, Pharmacovigilance, Quality, Commercial, Legal, Compliance, and Global Regulatory Affairs.

Requirements

• Experience in Japanese post-approval regulatory affairs and compliance.
• Ability to maintain Japanese Package Inserts and manage related regulatory activities.
• Knowledge of PMDA, MHLW, and JPMA regulations, guidance, and industry practices.
• Ability to provide regulatory guidance on promotional, scientific, and medical communications.
• Ability to build strong relationships with Japanese health authorities and identify regulatory risks and opportunities.

Culture & Benefits

• Hybrid work environment supported by modern collaboration technology and IT services.
• Flexible working hours and vacation programs.
• Retirement, stock compensation, and employee stock purchase opportunities.
• Internal and external training, LinkedIn Learning, specialized professional training, and AI-enabled learning tools.
• Global recognition programs and employee resource group activities.