Sr. Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs – Japan Alnylam K.K.

The Senior Manager, Regulatory Affairs, Japan reports to the Head of Regulatory Affairs and plays a key role in supporting the development and execution of regulatory strategies for development and/or commercial programs in Japan. This role partners closely with Global Regulatory Affairs and cross-functional stakeholders to support clinical development, regulatory submissions, approvals, and lifecycle management activities in Japan. The Senior Manager contributes to regulatory strategy, leads key regulatory activities, and represents Japan Regulatory Affairs on project teams.

Regulatory Strategy and Execution •Contribute to the development and implementation of Japan regulatory strategies for assignedprograms, ensuring alignment with global objectives and local regulatory requirements •Provide regulatory input to cross-functional teams, identifying potential risks and supportingmitigation strategies •Represent Japan Regulatory Affairs on global project teams and sub-teams, contributing todiscussions and decision-making Regulatory Submissions and Health Authority Interactions •Lead the preparation and submission of regulatory documents to PMDA/MHLW incompliance with applicable regulations, including: 　oClinical Trial Notifications (CTNs) 　oHealth Authority meeting materials 　oMarketing Authorization Applications 　oOrphan designation and expedited pathway applications •Support interactions with Japanese Health Authorities, including preparation forconsultations and meetings •Coordinate timely and high-quality responses to Health Authority inquiries Execution and Operational Excellence •Develop and manage Japan regulatory plans and timelines for assigned programs, ensuringeffective execution of deliverables •Collaborate with CROs and external partners to support regulatory activities, ensuring qualityand compliance •Maintain regulatory documentation in accordance with internal standards and regulatoryrequirements •Support continuous improvement of regulatory processes, systems, and ways of working Collaboration and Capability Building •Partner with Clinical, Medical, Quality, CMC, and Commercial teams to support integrateddevelopment and commercialization strategies •Provide guidance and share expertise with team members, contributing to team effectivenessand capability development •Demonstrate strong commitment to ethics, compliance, and Alnylam Core Values Qualifications •Bachelor’s degree in science or a related discipline required; advanced degree preferred •Typically, 6–10 years of experience in Regulatory Affairs within the pharmaceutical,biotechnology, or related healthcare industry, including experience in Japan regulatoryactivities •Working knowledge of Japanese pharmaceutical regulations and ability to apply regulatoryguidance effectively •Experience supporting or leading regulatory submissions and Health Authority interactions •Strong communication skills in both Japanese and English •Solid problem-solving, organizational, and project management skills with the ability tomanage multiple priorities Alignment with Alnylam Core Values Commitment to People · Innovation and Discovery · Sense of Urgency · Open Culture · Passion for Excellence · Strong Compliance Mindset Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. シニアマネージャー／薬事（Regulatory Affairs）Alnylam Japan株式会社 ポジション概要 シニアマネージャー／薬事は、日本における開発および／または商業プログラムに関する薬事戦略の立案・実行をサポートする重要な役割を担います。Head of Regulatory