Description

Pipeline and On-Market Products Development and Maintenance from Regulatory perspectives

• Responsible and accountable for Renal Business Unit new product introduction and sustain product operation activity.
• Plan and execute necessary activities relating to drugs and medical devices.
• Establish regulatory strategy linked to global regulatory and sales marketing strategy.
• Manage regulatory activities relating to specific portfolio of products/projects

Qualifications

• Academic degree: Bachelor's degree in a scientific or chemical discipline, pharmaceutical, engineering, or related field. Master's and/or PhD degree is preferred.
• Experience: 3 years of pharmaceutical drug registration/medical device registration with concrete experience to prepare CTD/STED
• General Management skills
• People management skill・English: Strong written, verbal communication and presentation skills (TOEIC 750)・Knowledge　-Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.　-Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage.　-Exceptional attention to detail and ability to review and interpret technical documentation, scientific data, and regulatory guidelines accurately.