Senior Manager - Associate Director, Regulatory Affairs, Japan

Job Description:

The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds/biologics through all phases of development, post-approval, and life-cycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies in Japan. He/she will also provide line management, people development, and performance management as well as support/lead development and i...