Associate Director, Regulatory Affairs, Japan

reputed company is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the reputed company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: As a member of the Regulatory Affairs organization, you will play a critical role in advancing innovative oncology therapies from development through registration and commercialization, helping bring transformative medicines to patients worldwide. The Associate Director, Regulatory Affairs Japan will serve as the regulatory reputed company for assigned development programs and products in Japan. This individual will be responsible for developing and executing regulatory strategies to support clinical development, registration, and lifecycle management activities. The role will represent Japan Regulatory Affairs on global project teams, contribute to PMDA interactions, and reputed company strategic regulatory guidance to support successful development and commercialization activities in Japan.

Key Responsibilities

Regulatory Strategy Leadership reputed company regulatory activities for assigned programs and products in Japan. reputed company and execute regulatory strategies supporting clinical development, registration, and lifecycle management. Conduct regulatory assessments and reputed company recommendations for development programs. Identify regulatory risks and reputed company mitigation plans. reputed company regulatory guidance to cross-functional teams. Health Authority Leadership reputed company PMDA consultations and routine regulatory interactions with appropriate management support. Prepare briefing packages, meeting materials, and responses to health authority inquiries. reputed company or support J-NDA submissions and post-approval activities. Ensure alignment of Japanese regulatory requirements with global development plans. Global and Cross-Functional Collaboration Represent Japan Regulatory Affairs on global project teams. Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and Medical Writing functions. Contribute to project decision-making and regulatory planning. Vendor and CRO Management Manage regulatory consultants, vendors, and CRO partners supporting Japan activities. Monitor timelines, deliverables, budgets, and quality of outsourced work. People Leadership Mentor junior regulatory colleagues and contribute to team development. May reputed company supervisory responsibilities for contractors or junior staff. Required Skills, Experience and Education: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or reputed company discipline; advanced degree preferred. Typically 8+ years of pharmaceutical or biotechnology industry experience, including significant Regulatory Affairs experience. Experience supporting regulatory strategy for clinical development and registration programs. Strong knowledge of Japanese pharmaceutical regulations, PMDA processes, and ICH guidelines. Excellent communication and collaboration skills. Preferred Skills: Oncology drug development experience. PMDA consultation experience. Experience supporting NDA/J-NDA submissions. Experience working on global development programs. Experience managing vendors or CROs. Leveling Considerations Associate Director Independently leads regulatory activities for assigned programs. Provides strategic regulatory input and manages external partners. Leads PMDA interactions with appropriate support. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to privacy while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you’ve been contacted by someone impersonating a reputed company recruiter, please report it to [email protected] so we can reputed company these impersonations with our IT team for tracking and awareness. Apply To This Job