Summary of Job Description:

Manager II, Regulatory Affairs (RA) CMC Group, Regulatory Affairs Japan, is accountable for executing regulatory activities for projects with high complexity and strategic impact, acting as a senior core member and regulatory lead within project teams. This role drives robust regulatory strategies across the product lifecycle, ensures timely and high-quality regulatory deliverables, and maintains full compliance with applicable regulations and company policies.

In addition to project execution, the Manager II supports and develops RA team members, provides technical and strategic guidance, and contributes to team management within and across therapeutic areas, strengthening overall regulatory capability and operational excellence.

Major Responsibilities:

• Lead regulatory affairs activities for complex or high-impact projects across assigned therapeutic areas, includi...