senior manager, regulatory affairs.

Collaborate with a global team of experts in a company with over 170 years of history in advancing eye health and vision care.

求められる経験
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)

保険
健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険,介護保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,265 ～ 1,500万円

賞与
15%
雇用期間
期間の定めなし