メディカル・バイオ - 薬事申請

・Develop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations with regulations.
・Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies.
・Prepare documents for regulatory filing and agency consultation materials under PMD Act.
・Maintain regulatory documents to keep registration status.
・Manage clinical validation studies with clinical affairs.
・Represent the Regulatory Affairs function at multi-departmental meetings.
・Liaise with competent authorities and notified bodies to seek advice and guidance.

■休日：土, 日, 祝日, 夏季休暇, 年末年始

・Bachelor’s degree or above for chemical, pharmaceutical, medical, science, etc.
・Regulatory experience in the IVD or medical device industry
・Ability to plan multiple tasks and effectively prioritize activities
・Effective communicator with internal customers
・Proactive with proven ability to work under own initiative, and strong team player
・Fluent in Japanese and business level in English (oral and written)
・Excellent IT skills
・Pharmacist license holder preferred

■職種未経験者：不可