【Full-remote】In-Country Caretaker (API QA/CMC RA)

求人詳細

■Position Summary
A 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.

こんな方を求めています

経験・スキル

■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"

学歴

大学卒業以上

募集要項

職種

プロジェクトマネージャー、ディレクター

給与

年収 800 〜 1,100万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

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