The role involves managing regulatory activities for post-approval CMC changes, ensuring stable product supply, and providing regulatory information to support development processes.
1. Job Objective:
Responsible for regulatory activities related to post‑approval 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
Regulatory Information
Develop and manage internal process
3. Skill Requirements
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
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
薬事情報
社内プロセスの構築および管理
3．必要なスキル• 要件
必須要件
歓迎要件
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
Responsible for regulatory activities related to post‑approval 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（JPMA、DIA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
Top Skills
Cmc
GCP
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