【R&D】薬事申請グループ スタッフ / Post Approval Change Management
- Japan - Tokyo

Our Purpose
Our Values
Pfizer Research & Development
Benefits
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
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 AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)
