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 responsibilities based on regulatory and therapeutic area expertise, monitor progress, support team members, and ensure timely achievement of deliverables.
• Mentor and coach team members to support their professional and career growth.
• Direct involvement in development projects and life-cycle management activities, including Package Insert maintenance. Lead and implement local regulatory strategies as appropriate.
• Foster a collaborative and high-performing organizational culture within the RA TA group and with cross-functional teams.
• Liaise with key internal and external stakeholders (e.g., PMDA, MHLW, global teams) for cross-functional initiatives, including regulatory submissions and therapeutic projects.
• Identify, address, and resolve strategic and operational challenges impacting regulatory and therapeutic area activities.
• Contribute to regulatory policy intelligence and actively monitor relevant regulatory changes and developments.
• Ensure compliance with company policies and all applicable health authority regulations.