About the job
Job Summary:
The Senior Manager of the Regulatory Affairs Therapeutic Area (TA) Group leads a dedicated team of regulatory professionals focused on oncology within Regulatory Affairs Japan. This pivotal role ensures that the team operates efficiently and productively, fostering professional growth while delivering high-quality regulatory outputs promptly. The Senior Manager is responsible for developing and executing strategies that align with AbbVie's organizational goals, providing mentorship, and driving excellence across regulatory and therapeutic landscapes while managing various development projects.
Key Responsibilities:
- Manage and inspire the RA TA team by establishing clear objectives and performance metrics.
- Oversee the recruitment, onboarding, and continuous training of team members.
- Distribute projects and responsibilities based on expertise, monitor progress, and ensure timely completion of deliverables.
- Provide guidance and coaching to support team members' professional development.
- Participate directly in development projects and lifecycle management, including maintaining Package Inserts, and lead local regulatory strategy implementation.
- Cultivate a collaborative and high-performance culture within the RA TA group and across cross-functional teams.
- Engage with internal and external stakeholders (e.g., PMDA, MHLW, global teams) for regulatory submissions and therapeutic initiatives.
- Identify and resolve strategic and operational challenges affecting regulatory and therapeutic activities.
- Contribute to regulatory policy intelligence and keep abreast of relevant regulatory changes.
- Ensure adherence to company policies and compliance with all health authority regulations.