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The role involves researching Japanese commercial and regulatory legislation to support AI training and model evaluation. Responsibilities include annotating legal datasets, verifying statutory citations, and evaluating AI-generated legal responses for accuracy.
Manage complex regulatory strategies and life-cycle measures for medicinal products in Japan. Facilitate communication with health authorities like the PMDA and provide support to international clients.
The Corporate & Regulatory Counsel serves as the primary legal advisor for privacy compliance, managing regulatory requirements and incident response. This role also involves drafting commercial agreements and collaborating with cross-functional teams to implement privacy governance frameworks.
Lead the global data privacy strategy and framework while providing strategic leadership on compliance and risk management. Advise senior leadership on data privacy obligations and drive a privacy-by-design culture across the organization.
Develop CMC regulatory strategies and manage the preparation of marketing authorization applications for new drug development. Coordinate with clients and regulatory authorities (PMDA) to handle inquiries and ensure product approval and change management.
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Negotiate complex commercial and technology agreements across APJ markets, including SaaS and AI-related contracts. Develop regional legal templates and playbooks while providing strategic guidance to Sales leadership to balance risk and business growth.
The role involves drafting and negotiating commercial agreements and providing legal counsel on corporate governance and HR matters for Japan operations. Additionally, the attorney will manage external counsel and monitor regulatory developments to mitigate legal risks.
![Morunda K.K. is hiring for remote [Remote Work] Japan Regulatory Affairs Specialist](/assets/8da5480e-0f9f-4411-baeb-a5ec41c2d0bf.jpg){kind=small}
Coordinate compliant artwork development and regulatory submissions for the Japanese market. Manage documentation, version control, and cross-functional reviews between RA, QA, and partner companies.
Perform day-to-day operational activities to ensure compliance with regulatory, payment network, and partnership requirements in Japan. This includes monitoring and investigating alerts related to AML, fraud, sanctions, and prohibited business activities.
Lead regulatory activities and strategies for oncology programs in Japan, focusing on clinical development, registration, and lifecycle management. Act as the primary regulatory lead for PMDA interactions and represent Japan Regulatory Affairs on global project teams.
Manage claims and lawsuits brought against policyholders by interpreting coverage and overseeing outside legal counsel. Resolve cases through settlement, dismissal, or trial while managing litigation costs and reserves.
The consultant will review and negotiate a high volume of commercial contracts across multiple customers, ensuring adherence to playbooks and fast turnaround times. They will also directly engage with in-house legal teams at financial services companies, serving as a trusted legal advisor for contract negotiations.
The Regulatory Lead is responsible for maintaining Registered Certification Body Status and the PMDA Scheme in Japan, acting as the main liaison with the MHLW/PMDA and managing regulatory intelligence and audit interfaces. This role involves providing regulatory expertise to operations teams, supporting certification decisions, leading external audits, and managing all change notifications to regulatory bodies.
The role involves planning, preparing, and revising regulatory documents for various submissions, ensuring accuracy and compliance with regulations. It also includes collaborating with internal teams to author CMC regulatory content and providing assessments for manufacturing changes.
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