【full-remote】in-country caretaker (api qa/cmc ra).

■Position SummaryA global leader in the Pharmaceutical and Medical Device sectors is seeking a professional to join their In-Country Caretaker (ICC) officer in Japan. This role involves optimizing registration processes, compiling regulatory dossiers, and coordinating regulatory activities for product lifecycles on a worldwide level. The selected candidate will act as a project manager for Japanese projects, managing resources and budgets, while providing regulatory advice and support for the Master Files of foreign companies.■Responsibilities- Master File Management: Manage the registration of Foreign Manufacturers of Active Substances, including the preparation, translation, and formatting of Japanese Master Files (MF) from English Data Master Files.- PMDA Interaction: Handle submissions to the PMDA, manage official communications, and translate necessary documentation between Japanese and English.- Project Management: Act as the project manager for all Japanese projects, overseeing resource planning, budget control, and serving as the primary contact point for customers.- Regulatory Intelligence & Strategy: Provide high-quality information on Japanese regulations when required and assist the business development team with new services.- Compliance & Accreditation: Manage Site Accreditation and ensure that all submissions are of high quality and meet all regulatory requirements.*This position can be done fully remote from anywhere in Japan. Will need to travel to the office in Osaka around 2-3 times/year for a company-wide meeting.

求められる経験
■Requirements
- Experience: A minimum of 5 years of experience in CMC Regulatory Affairs or API Quality Assurance in Japan, with a preference for experience in API registration or ICC.
- Fluent-level proficiency in Japanese & English
- A strong understanding of Japanese regulations and guidance is essential.
- Previous experience in project management is required.
- Experience in GMP auditing or EU/US registration processes is considered a "nice to have"

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収800 ～ 1,100万円

賞与
-
雇用期間
期間の定めなし