薬制薬事担当者 / Regulatory Affairs expert

Background to Recruitment :

With the increase and progress of development of drugs, medical devices, advanced therapy products, etc., persons who have expertise of regulatory affairs in Japan and overseas are being recruited.

GQP / GVP部門との連携等）

GMP / QMS / GCTP適合性調査（承認前調査 / 定期調査）、外国製造業者認定の維持・管理業務

Description of Work :

Maintain and manage the regulatory requirement compliance system

of business license holder : creating and maintaining Standard

Operating Procedures, secretariat of the meeting, cooperation with quality and pharmacovigilance division."

Measures to address product risk issues such as product recall and counterfeiting in Japan and overseas affiliates.

Lead regulatory intelligece activity to develop and market products including new modalities (medical devices and human cell therapy and gene therapy products).

Consultation to any query related Pharmaceutical Regulation for in-house customer.

Maintain the MAH in overseas and project management (coordination) of product related regulatory tasks.

Management of the official documents, which given by HA or submitted by the company.

Daily check / primary assessment of Japanese and Global (US / EU / Asia) regulatory requirements and news.

GMP / QMS / GCTP inspections (Pre-Approval inspections and Periodic inspections)

Maintain and manage of Accreditation of Foreign Manufacturers

Survey to CMO related to manufacturing and testing methods 応募資格／Qualifications 求める経験：

Desired Experience :

Bachelor's or master's degree in Pharmacy, Science or Engineering with experience in the pharmaceutical industry

Experiences of general regulatory affairs

GMP / QMS関連規制に関する知識

Desired Skills :

Systematic knowledge on the whole of the PMD Act.

Knowledge of general regulatory affairs (NDA, change control, GMP / QMS related regulation etc.) in Japan.

Regulatory filing in Global

Experiences in manufacturing or QA

Project lead or management skills

Desired Competencies :

Building good relationship inside and outside the company

Honesty

Desired Qualification：

Working-level of written and spoken English

Position Features：

There is an increasing need to handle a wide range of regulatory affairs concerning not only medicines, which are the mainstay of our company, but also the entire lifecycle of medical devices and regenerative medicine products. This is a challenging job where you can widely experience pharmaceutical affairs operations while collaborating with many stakeholders in Japan and overseas. 待遇／Salary & Benefits 当社規定により優遇いたします。

To be decided in accordance with our criteria

Flextime system

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.