募集要項

募集背景: As a Senior Regulatory Affairs Manager, you will oversee regulatory compliance and execute strategies for pharmaceuticals, quasi-drugs, and medical devices in the Japanese healthcare market. Your role involves providing expertise in managing business licenses and ensuring adherence to current regulations. You'll be responsible for identifying opportunities to enhance compliance with the latest regulatory requirements and optimize processes. This position is crucial for maintaining the company's regulatory standing and supporting business operations in Japan's healthcare sector.

仕事内容: Main Responsibilities:
● Perform the following tasks as the primary or team leader as directed.
● Planning of regulatory strategy
● Regulatory submissions (notification, certification, and approval)
● Consultation and negotiation with Japan authorities (MHLW, PMDA, the prefectural governments, etc.)
● Regulatory assessment for change control/ management
● Support for new product development from the RA perspectives
● Support for new business development from the RA perspectives
● Attendance of trade association activities, and regional/ global regulations updates
● Regulatory review of promotional materials
● Regulatory review of packaging, labeling, package insert, and IFU, etc.
● QMS submission and foreign manufacturing registration
● Renewal and maintenance of business licenses (pharmaceuticals, quasi drugs, and medical devices)
● Document control and information disclosure
● Development and operation of quality management system in regulatory affairs
● Regulatory intelligence

応募資格

必須: Qualifications:
● Bachelor's degree (BA/BS) in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medicine, or law
● Advanced degree or additional professional training preferred
● Pharmacist license desirable

Experience:
● 10+ years of experience in Regulatory Affairs within the healthcare industry
● Proven track record of successful submissions and approvals for pharmaceuticals, quasi-drugs, and medical devices (Class III or IV), including QMS submissions and/or foreign manufacturing registrations
● 5+ years of experience in recruiting, educating, and managing Regulatory Affairs team members in the healthcare sector
● Strong communication skills and ability to respond quickly and appropriately to Japanese authorities

Required skills:
● Strong leadership and accountability in the global healthcare business
● Hands-on experience with regulatory submissions, approvals, QMS submissions, and/or foreign manufacturing registrations
● Comprehensive knowledge of Japanese regulations, including PAL, ISO, IEC, and other related international regulations
● Scientific and clinical knowledge to understand technical documents and academic articles
● Analytical, problem-solving, and project management skills
● Excellent oral and written communication skills in both Japanese and English
● Business-level English proficiency (reading, writing, and verbal)

会社概要

事業内容・会社の特長: A leading global provider in eye health, this company offers a comprehensive range of products designed to improve vision and enhance the quality of life for people around the world. Their extensive portfolio includes contact lenses, lens care products, ophthalmic pharmaceuticals, and surgical devices, catering to various needs from routine vision correction to advanced medical treatments. With a longstanding commitment to innovation, research, and development, they continuously strive to deliver cutting-edge solutions and maintain the highest standards of quality and safety in their offerings.