[DJ] 非臨床開発研究部 [DSRD] リサーチアンドディベロップメントサイエンティスト（専門管理職・一般社員）/Research and Development Scientist （Research & Development Scientist / DSRD-Tokyo）
Pfizer · JP
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About the Role
This role is responsible for drug approval applications in Japan, specifically focusing on non-clinical aspects (pharmacology, pharmacokinetics, toxicology). It involves creating regulatory documents, responding to inquiries from authorities, and aligning global development strategies with Japanese non-clinical research and development strategies. The position also entails disseminating information within Japan regarding non-clinical research and development expertise and identifying opportunities for joint research through scouting Japanese scientific advancements.
Responsibilities
- Participate as a non-clinical expert in Japanese development project teams, providing specialized scientific knowledge and expertise.
- Understand scientific knowledge, competitor landscape, and regulatory guidelines for development targets.
- Monitor progress and potential obstacles in projects, communicating findings to the team.
- Oversee the progress of global non-clinical studies and provide updates to the team.
- Contribute as an expert on non-clinical regulatory guidelines to Pfizer DJ (R&D) and Pfizer Japan.
- Represent DSRD in meetings with regulatory authorities such as PMDA.
- Prepare non-clinical regulatory documents (e.g., PMDA consultations, CTPN, CTD) and collaborate with global counterparts to address PMDA inquiries.
- Adapt global regulatory documents to Japanese standards and conduct comprehensive non-clinical evaluations.
- Ensure timely creation of non-clinical regulatory documents, including reviews, according to project timelines.
- Collaborate with global counterparts to ensure regulatory document content and format comply with Japanese standards.
- Develop and execute non-clinical research and development strategies in Japan.
- Develop and implement risk management strategies in Japan.
- Develop and execute internal and external influence strategies to support the initiation of clinical trials by outlining the necessity of non-clinical studies.
- Investigate and gather information on the current state of science in Japan, introducing it to the Global Non-clinical R&D division as Open Innovation, and building opportunities for joint research.
Requirements
- Master's degree or higher in medicine, pharmacology, biology, or equivalent, or a veterinarian degree.
- Knowledge of international pharmaceutical regulatory guidelines and safety assessment.
- Skills in preparing pharmaceutical regulatory documents.
- English documentation and communication skills sufficient for job execution.
- Scientific knowledge in the field of new modalities.
- Good communication skills.
- Experience collaborating in matrix and multi-line organizations.
- Practical experience in pharmaceutical research and development.
- Practical experience in animal testing (e.g., toxicology studies).
- Experience in global pharmaceutical regulatory affairs.
Skills
- Non-clinical expertise (pharmacology, pharmacokinetics, toxicology)
- Regulatory document preparation (IB, CTD)
- Communication with regulatory authorities (PMDA)
- Global development strategy alignment
- Information gathering and scouting
- Risk management
- International regulatory guidelines
- Safety assessment
- New modalities scientific knowledge
Location
- Tokyo Headquarters
- Japan
Work Type
- Hybrid
Education Level
- Master's degree or higher in medicine, pharmacology, biology, or equivalent
- Veterinarian degree
About the Company
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
- To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Equal Opportunity
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.