Manager II, Regulatory Affairs(Immunology)

Summary of Job Description:

Manager II, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities for projects with high complexity and strategic impact, acting as a senior core member and regulatory lead within project teams. This role drives robust regulatory strategies across the product lifecycle, ensures timely and high-quality regulatory deliverables, and maintains full compliance with applicable regulations and company policies.

In addition to project execution, the Manager II supports and develops RA team members, provides technical and strategic guidance, and contributes to team management within and across therapeutic areas, strengthening overall regulatory capability and operational excellence.

Major Responsibilities:

• Lead regulatory affairs activities for complex or high-impact projects across assigned therapeutic areas, including preparation, review, and oversight of regulatory submissions (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW.
• Serve as a regulatory lead and key strategic partner within cross-functional project teams (e.g., Clinical Development, Project Management, Commercial), providing proactive and solution-oriented regulatory input throughout product life-cycle management.
• Develop, optimize, and implement regulatory strategies that address complex regulatory challenges while ensuring alignment between global and Japan-specific requirements.
• Act as a senior point of contact for interactions with PMDA/MHLW, leading regulatory communications, facilitating issue resolution, and guiding teams through complex regulatory discussions.
• Identify, assess, and manage regulatory risks, including scenario planning and development of contingency strategies for complex programs.
• Coach, support, and train RA team members, sharing expertise, reviewing key deliverables, and contributing to talent development and capability building within and across TAs.
• Contribute to team management and cross-TA collaboration, including knowledge sharing, process improvement initiatives, and alignment of regulatory practices.
• Lead or significantly contribute to departmental and cross-functional initiatives to enhance regulatory processes, operational efficiency, and regulatory excellence, if applicable.

Essential Skills & Abilities:

• Advanced Regulatory Expertise: Strong and practical knowledge of Japan’s regulatory requirements, procedures, and PMDA/MHLW expectations, with the ability to manage complex regulatory issues.
• Project Management: Proficiency in planning, executing, and monitoring projects to ensure delivery within scope and timelines.
• Problem-Solving: Strong analytical skills with a proactive, risk-based approach to resolving complex regulatory and operational challenges.
• Leadership & People Development: Ability to mentor and support team members, foster knowledge sharing, and positively influence team performance.
• Communication: Excellent verbal and written communication skills in Japanese and business level in English, with the ability to influence cross-functional and global stakeholders.
• Compliance Orientation: Exceptional attention to detail with a robust understanding of regulatory frameworks and industry requirements.

Education / Experience Required:

• Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering).
• Substantial experience in regulatory affairs within the pharmaceutical or healthcare industry, including hands-on leadership of regulatory submissions and PMDA interactions.
• Extensive project experience in new drug development and life-cycle management, with demonstrated ability to manage complex or high-risk programs.
• Experience guiding or mentoring junior team members and contributing to team or functional leadership is strongly preferred.

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。