Manager, RA CMC Group, Regulatory Affairs

Summary of Job Description:
Manager, Regulatory Affairs (RA) CMC Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes.

Major Responsibilities:

• Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, GMP Applications, Licensing Applications) to PMDA/MHLW/local authorities.
• Collaborate with cross-functional project teams (e.g. RA TA Group, Commercial QA, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
• Lead and implement CMC regulatory strategies, considering both global and local requirements.
• Interact with PMDA/MHLW/local authorities and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
• Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
• Support the development and maintenance of regulatory SOPs and best practices, if applicable.
• Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.

Essential Skills & Abilities:

• Regulatory Knowledge: Solid understanding of Japan’s regulatory requirements and procedures.
• Teamwork: Effective collaboration in multi-functional teams; openness to learning and knowledge sharing.
• Project Management: Ability to handle multiple projects, prioritize tasks, and consistently meet deadlines and quality standards.
• Problem-Solving: Analytical and proactive approach to identifying and resolving regulatory and operational issues.
• Communication: Verbal and written communication skills in Japanese and business level in English, with proven ability to collaborate cross-functionally and manage diverse 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).
• Experience in regulatory affairs within the pharmaceutical or healthcare industry is required, including preparation or review of regulatory submissions.
• Direct project experience (new drug development and life-cycle management) strongly preferred.
• Experience managing communications with regulatory authorities is valued.

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。