R&D Post Approval Change Management

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

1. Job Objective:

Responsible for regulatory activities related to postapproval CMC (Chemistry Manufacturing and Controls) change management for pharmaceutical products contributing to the maintenance of a stable and continuous product supply.

2. Job Roles and Responsibilities:

Post approval CMC change management

Manage product approval changes in order to keep stable product supply.
Manage the changes for manufacturer of drugs and develop regulatory strategies for application for partial change.

Regulatory Information

Provide regulatory information to Development Japan (DJ) by collecting analyzing and leveraging pharmaceutical industry trends and practices to support development and regulatory strategy development.

Develop and manage internal process

Develop and manage internal processes including processes that involve cross-functional collaboration.

3. Skill Requirements

BASIC QUALIFICATIONS

Graduated science college/university
Knowledge and understanding of local regulatory law and practical skills
A positive candidate with a strong sense of teamwork good communication skills and the ability to demonstrate leadership.
Basic knowledge of society in general as well as science and technology
English speaking/hearing and writing skill to work smoothly with global colleagues
Basic IT skills

PREFERRED QUALIFICATIONS

Basic knowledge of Drug Characteristics and Drug manufacturing
Experiences outside activities (JPMA DIA etc.)
Experience PMDA interaction related to CMC

1主な職務における成果責任

医薬品の承認後CMC (Chemistry Manufacturing and Controls)変更管理の薬事関連業務を担い安定的かつ継続的な製品供給の維持に貢献する

2職務内容および責任

承認後CMC変更管理

安定した製品供給を維持するため承認事項に関わるCMC変更を管理する
医薬品製造業者に関する変更を含むCMC変更について一部変更承認申請等に向けた薬事戦略の立案および当局対応を行う

薬事情報

開発および薬事戦略の構築を目的として製薬業界の動向や運用事例に関する情報を収集分析しDevelopment Japan (DJ) へ薬事情報として提供する

社内プロセスの構築および管理

部門横断的に連携するプロセスを含む社内プロセスの構築および管理を行う

3必要なスキル要件

必須要件

理系学部大学卒業
薬機法GCP等の規制要件を理解し遵守できる方
前向きでチームワークを大切にし円滑なコミュニケーションが取れリーダーシップを発揮できる方
社会一般および科学技術に関する基礎的知識
グローバルメンバーと円滑に業務を進めるための英語による会話読解文書作成能力
基本的なITスキル

歓迎要件

医薬品の特性および製造に関する基礎知識
業界団体JPMADIA等における社外活動経験
CMCに関連したPMDA対応の実務経験

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

1. Job Objective:Responsible for regulatory activities related to postapproval CMC (Chemistry Manufacturing and Controls) change management for pharmaceutical products contributing to the maintenance of a stable and continuous product supply. 2. Job Roles and Responsibilities:Post approval CMC chang...