Director, Regulatory Affairs - Japan

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: The Director, Regulatory Affairs Gene Therapy will be responsible for guiding strategy, identifying risks, interpreting regulations, and providing guidance to ensure regulatory compliance for all gene therapy related regulatory activities in Japan. This person will also be responsible for the development of assigned programs in alignment with Insmed’s business needs in Japan. Support to other Regions may be requested to ensure business needs are met for the overall gene therapy portfólio. What You'll Do: The Director Regulatory Affairs Gene Therapy in Japan will be responsible for: Independently, or in collaboration with the gene therapy regulatory program lead, serve as the regulatory representative for all gene therapy related activities in Japan Presenting regulatory strategies and risk assessments for Japan to cross-functional teams and senior leadership, as needed Collaborate with the broader gene therapy regulatory team, Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory deliverables in Japan and ensure strategic integration of regulatory considerations for Japan are incorporated into the overall program plans, as needed Independently lead the strategic messaging, preparation, and submission of high quality, regulatory complaint regulatory dossiers in Japan for the gene therapy team Direct hands-on experience with key regulatory dossiers submitted to the Japanese Health Authorities including, but not limited to, meeting requests, Orphan drug applications, RS strategy consultation meeting briefing documents, Cartagena applications, and CTNs Preparing and leading regulatory discussion with the Japanese Health Authorities for all gene therapy programs in Japan Proactively communicating issues, outcomes, and risks within Japan to the VP of Regulatory Affairs Gene Therapy and to all relevant parties/teams With the necessary oversight from the VP of Regulatory Affairs Gene Therapy, lead the development and implementation of regulatory strategy plans in Japan to facilitate efficient and competitive product development in this region Monitor the evolving regulatory competitive landscape in Japan to identify potential opportunities and areas of risk to assigned programs. Additional responsibilities will include, but not necessarily be limited to, the following: Provide strategic regulatory guidance and input in problem solving and issue resolution as it relates to gene therapy development in Japan. Develop risk mitigation plans in Japan for key stakeholders Provide regulatory review of documentation prepared by other technical functions supporting product development activities in Japan (e.g., clinical protocols, clinical study reports, statistical analysis plans, CMC related documentation, etc.) in accordance with Japanese regulatory guidelines/requirements Provide leadership and management for the coordination and preparation of submissions to the Japanese regulatory bodies consistent with regulatory requirements and in accordance with corporate strategy and timelines Ensure accuracy and consistency of regulatory submissions and correspondence in Japan. Manage vendor/consultant roles, where applicable. Lead the planning and conduct of meetings and communication with the ... (truncated, view full listing at source)