About the job
The Senior Manager of the Regulatory Affairs (RA) Therapeutic Area (TA) Group in Japan is pivotal in guiding a dedicated team of regulatory professionals focused on the oncology sector. This role is essential for ensuring streamlined operations, enhanced productivity, and the continuous professional growth of team members while delivering precise regulatory outcomes efficiently. The Senior Manager will formulate and execute strategic initiatives that resonate with corporate goals, inspire team leadership, mentor personnel, and maintain operational excellence in regulatory and therapeutic domains, all while managing development projects as required.
Key Responsibilities:
- Direct and manage the RA TA team by establishing clear objectives and performance metrics.
- Oversee the recruitment process, onboarding, and ongoing professional development for team members.
- Distribute projects and tasks according to team members' expertise, monitor their progress, provide necessary support, and ensure timely completion of responsibilities.
- Mentor and coach team members to foster their professional growth and career advancement.
- Engage directly in development projects and lifecycle management, including maintaining Package Inserts. Lead the formulation and implementation of local regulatory strategies as needed.
- Promote a cooperative and high-performance culture within the RA TA group and across cross-functional teams.
- Collaborate with key internal and external stakeholders (e.g., PMDA, MHLW, global teams) on regulatory submissions and therapeutic initiatives.
- Identify, tackle, and resolve strategic and operational challenges affecting regulatory and therapeutic activities.
- Contribute to regulatory policy intelligence and keep abreast of relevant regulatory changes and developments.
- Guarantee compliance with corporate policies and applicable health authority regulations.