Summary of Job Description:

The Senior Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is responsible for leading a team of RA TA professionals within the assigned therapeutic area. This role ensures effective workflow, optimal productivity, professional development, and delivery of high-quality regulatory outputs in a timely manner. The Senior Manager develops and implements group strategies aligned with organizational objectives, provides leadership, mentors staff, drives operational excellence in both regulatory and therapeutic domains, and actively manages development projects as needed.

Major Responsibilities:

• Lead and manage the RA TA team by setting clear objectives and performance expectations.
• Oversee recruitment, onboarding, and ongoing training and development for all team members.
• Allocate projects and resp...