Associate Director, Japan Regulatory Affairs (RA) CMC, Plasma Derived Therapies (PDT)

Role summary

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This role leads Japan regulatory CMC activities for Takeda’s Plasma Derived Therapies portfolio. The successful candidate will develop regulatory strategies, prepare and review CMC sections of submissions, manage interactions with Japan’s PMDA and Ministry of Health, Labour and Welfare, and support approvals, variations, renewals, and post-approval commitments. Applicants are expected to have substantial pharmaceutical regulatory experience, particularly in CMC, biologics, plasma-derived products, or related manufacturing technologies. Strong knowledge of Japanese regulatory requirements, project leadership skills, and the ability to work effectively with global technical, quality, manufacturing, and clinical teams are important. Professional Japanese and English communication skills are likely required, together with sound scientific judgment, organization, and the ability to influence stakeholders in a complex multinational environment.

About the employer

Takeda Pharmaceutical Company is a Japan-headquartered global biopharmaceutical organization with operations in more than 80 countries and regions. Founded in Osaka, the company focuses on medicines for gastroenterology, rare diseases, plasma-derived therapies, oncology, and neuroscience. Takeda combines Japanese heritage with international research, manufacturing, and commercial capabilities. Its Plasma Derived Therapies business develops and supplies treatments made from human plasma for patients with immune deficiencies, bleeding disorders, and other serious conditions. The company emphasizes patient needs, scientific innovation, ethical conduct, quality, and collaboration across geographic and functional teams. Takeda employs a large international workforce and offers careers spanning research, clinical development, manufacturing, regulatory affairs, supply chain, commercial operations, and corporate functions. The company’s Osaka presence is particularly significant for employees interested in working close to its Japanese roots while contributing to global pharmaceutical programs.