Description
We are seeking a Regulatory Affairs Specialist to join our team in Tokyo, Japan.
Job Summary The successful candidate will be responsible for handling regulatory affairs related to pharmaceuticals in Japan, including preparation of regulatory documents, responding to queries from regulatory authorities, and providing scientific expertise to internal stakeholders.
Responsibilities
- Participate in development project teams as a non-clinical expert, providing specialized scientific knowledge and know-how
- Monitor project progress, potential issues, and communicate with the team
- Review and contribute to regulatory documents, including PMDA consultations, CTPN, and CTD
- Collaborate with global colleagues to prepare comprehensive non-clinical evaluations
- Develop and execute non-clinical research and development strategies in Japan
- Provide input on risk management strategies in Japan
Requirements
- Master's degree or higher in medicine, pharmacy, biology, or veterinary medicine
- Knowledge of international regulatory guidelines and safety evaluation
- Experience in preparing regulatory documents for pharmaceuticals
- Strong English language skills for document creation and communication
- Familiarity with new modalities in the scientific community
- Excellent communication skills
- Ability to work in a matrix organization and collaborate with multiple teams
- Practical experience in pharmaceutical research and development
- Experience with animal experiments, particularly toxicity testing
- Global regulatory filing experience
Work Environment
- Location: Tokyo, Japan
- Employment type: Full-time
- Office worker (Hybrid)