Summary of Job Description:
Manager, Regulatory Affairs (RA) CMC Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes.
Major Responsibilities:
- Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, GMP Applications, Licensing Applications) to PMDA/MHLW/local authorities.
- Collaborate with cross-functional project teams (e.g. RA TA Group, Commercial QA, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
- Lead and implement CMC regulatory strategies, considering both global and local requirements.
- Interact with PMDA/MHLW/local authorities and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
- Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
- Support the development and maintenance of regulatory SOPs and best practices, if applicable.
- Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.