Regulatory Affairs Specialist, Tokyo, Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. 当社では薬事部門で活躍するRegulatory Affairs Specialistを募集します。 製薬メーカーやバイオテック企業をクライアントとするプロジェクトに従事し、治験届・当局対応・薬事コンサルテーション・CMC薬事・申請書類作成およびレビュー・事業拡大に関わる業務を担います。 **What you will be doing** + Undertaking variable duties based on project requirements, primarily within Pharmaceutical, BiotechNlogy, or Biologics Regulatory Affairs, with potential involvement in related areas. + Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation. + Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions. + Providing input to the Regulatory Intelligence function and participating in readability testing. + Reviewing IMPD/IB Core Docs and labeling for clinical trials. + Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature. + Facilitating business development activities as needed. **Your profile** + 理系の大学または大学院を修了していること。製薬メーカーやCROにて薬事業務に関連する知識と経験を2～3年程度有していること。ビジネスレベルTOEICスコア800以上の英語力を有すること。プロジェクトやチームへの貢献とコミュニケーションスキルを有すること。 + Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred. + Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry. + Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals. + Familiarity with label review, translation requirements, and regulatory intelligence activities. + Strong attention to detail and excellent communication skills. **What ICON can offer you:** Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family’s needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations) Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply