노바티스에서 비임상 안전성 전문가를 채용합니다. 신약 승인 신청(NDA) 및 독성 평가 전략을 주도하며, 비임상 안전성 분야의 실무 경험과 GLP 환경에 대한 이해가 필수입니다. 일본어와 영어 능통자를 우대하며, 최신 모달리티 독성 평가 경험이 있다면 더욱 좋습니다. 글로벌 팀과 협업하여 혁신적인 의약품 개발을 이끌어갈 인재를 찾습니다.
Job ID
REQ-10082103
Jul 01, 2026
Japan
で利用可能: 日本語
Drive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan.
Authoring responsible parts of J-NDAs, response to PMDA and all of the other activities for submission if necessary.
Assessment of pharmacological and/or toxicological profiles of early projects to contribute to Japan development strategy.
Roles as JPT/JST members
Support of TM clinical studies as pharmacologists and/or toxicologists including protocol/ICF review, IB review and interaction with HAs.
Seeking opportunity of proposals about new development programs/ indications
Participate/support initiatives, task-forces, and cross-functional activities in Dev./NPKK.
Quality management responsibility
Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
100% timely delivery of all training requirements including compliance
· Appropriate quality and timing of NDA and post NDA activities
· Appropriate quality and timing of pharmacological and/or toxicological profiling/evaluation of early projects
· Appropriate quality and timing of study supports
Education: MSc or PhD in life sciences (Pharmacology, toxicology, Pharmaceutics, other specific sciences), DVM/MD or equivalent professional experience.
· Experience/Professional requirement:
· Taking education or possessing knowledge of basic medicine, such as physiology, pharmacology, toxicology, anatomy/histology, molecular biology, etc.
· For mid-carrier employee, experience in pharmacology, toxicology or relevant field of the pharmaceutical Industry, CRO, academia, etc.
Appropriate skills of English (read/write and oral)
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Division
Biomedical Research
Business Unit
Development
Location
Japan
Site
Toranomon (NPKK Head Office)
Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
ノバルティス は 障害 を 持 つ 個人 と 協力 し、 合理的配慮 を 提供 することをお 約束 します。健康状態 や 障害 を 理由 に 採用 プロセス のいかなる 部分 においても、あるいは 職務 の 必須事項 を 果 たすた めに 合理的配慮 が 必要 な 場合 は midcareer-r.japan@novartis.com 宛 てに 電子 メール をお 送 りください。その 際 ご 依頼内容、 ご 連絡先、求人票 の 番号 を 明 してください。
Research & Development Biomedical Research Japan
Job ID
REQ-10082103
Job ID
REQ-10082103
