Primary Function / Primary Goals / Objectives:

The primary function of the Head of Regulatory Affairs in Japan is to act as the representative of the regulatory affairs organization to the Japan affiliate, and is a member of AbbVie Management Team in Japan. The incumbent will ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. The incumbent will have in-depth knowledge of the regulatory requirements and regulatory authorities in Japan. This expertise will also include but not be limited to the monitoring and influencing changes in regulatory policy and intelligence in Japan. The incumbent will oversee and manage the RA organization in Japan, including identification of resource needs and tasks in line with business priorities.

Major Responsibilities:

• Accountable for day-to-day management of the regulatory team in Japan, including effective assignment of team member responsibilities, planning, and prioritization of resources.
• Develop and manage Japan RA personnel through coaching, feedback, performance reviews, and development plan discussions.
• Responsible for performance management of Japan RA personnel and for developing team members, into successors and/or more senior leaders within the organization.
• Assess the training and development needs of Japan RA personnel and ensure execution of development plans, taking both technical expertise and leadership capabilities into consideration.
• Manage competing priorities in partnership with the General Manager, local cross-functional teams in Japan, and in consultation with RA leadership teams.

• Serve as the primary RA interface with Japan Commercial and cross-functional teams, providing strategic input for registration. Ensure business needs are met by anticipating and mitigating regulatory risks, ensuring compliance with regulations, and assessing the probability of success for submission, approval, and launch in Japan.
• Collaborate with other R&D functions, providing strategic regulatory input on matters including, but not limited to, clinical development, inspection, and safety.
• Oversee RA members and ensure they effectively represent Japan regulatory requirements and interests to the Area and Global Regulatory Product Team (ARPT/GRPT) to ensure these are met.
• Oversee the preparation and review of regulatory submissions, agency meetings, and communications to deliver optimal data presentations and regulatory responses, effectively delivering regulatory plans.
• Provide leadership and guidance to RA personnel in Japan in assessing scientific data from specialist units for registration purposes against Japan regulatory requirements, identifying gaps and developing mitigation strategies to ensure successful registration of new products (including clinical trial applications). Ensure effective presentation of data and complete, timely responses to regulatory authorities.
• Effectively engage and interface with Japanese regulatory authorities on key priorities and projects.
• Build trustworthy relationships with MHLW and PMDA, fostering effective communication and collaboration regarding AbbVie’s strategy
• Identify, plan, and engage with industry associations relevant to the AbbVie business.
• Take a leading role in relevant committees within pharmaceutical associations such as EFPIA Japan or JPMA to stay informed about the regulatory environment in Japan and help shape the external environment based on AbbVie priorities.
• Ensure regulatory compliance within Japan; propose new or revised policies as needed, and review or implement remediation plans to address identified gaps
• Ensure implementation and adherence to regulatory policies once established.
• Maintain active awareness of the legislative environment in Japan, assess the impact of any updates on AbbVie business, and communicate effectively across the organization, including but not limited to the Area Regulatory Team and the Regulatory Policy and Intelligence group.
• Support long-range planning and Future Fit initiatives in Japan, and provide regulatory counsel on selected business development activities as required.
• Oversee the regulatory affairs budget for Japan, including effective management of employee-related resources, and monitor adherence throughout the financial year.
• Lead the implementation and maintenance of processes and systems as appropriate; review global process implementation, suggest improvements to current processes, or develop new processes as required.
• Comply with Company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie.