PMS Planning & Management Head

Job Title : PMS Planning and Management Head • Location: Tokyo, Japan --- About the Job As PMS Planning and Management Head within our Regulatory Affairs & Patient Safety team, you'll lead a high-performing group responsible for shaping post-marketing surveillance strategy, driving regulatory excellence, and ensuring the safety of patients who depend on our medicines. Ready to get started? Ready to push the limits of what's possible? Join Sanofi in a senior leadership role at the heart of our regulatory and patient safety mission — where your strategic vision and scientific expertise will directly influence how we protect patients and engage with regulatory authorities in Japan and beyond. In this role, you'll lead a dedicated team, champion innovation in post-marketing surveillance, and play a pivotal part in the performance of our entire medicines portfolio. --- About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. --- Main Responsibilities • Lead and develop a high-performing team — build a strong, agile group grounded in strategic and scientific thinking, empowered to plan, execute, and report on post-marketing surveillance (PMS) activities with excellence and without being constrained by conventional approaches. • Drive PMS strategy and planning — design and oversee scientifically appropriate PMS programs (including usage surveys, database studies, and post-marketing clinical trials) tailored to each product's profile, drawing on clinical trial data, global risk management practices, and regulatory commitments. • Own regulatory authority engagement — lead negotiations with regulatory authorities, respond to inquiries, manage re-examination application conformity inspections, and represent the team in regulatory consultations with confidence and scientific rigor. • Oversee the full PMS lifecycle — guide the team through study outline development, protocol and case report form creation, global approval processes, analysis plan formulation, CSR preparation, and periodic safety reporting. • Champion cross-functional collaboration — build and sustain strong partnerships with Development, Medical, Safety, Regulatory Affairs, and Commercial teams — including global stakeholders — to ensure aligned, timely, and compliant PMS execution. • Develop talent and shape the future of the function — mentor and grow team members, foster a culture of continuous improvement, and drive modernization of processes in line with evolving regulations and the external environment. --- About You Change leadership and innovative mindset: A genuine drive to challenge the status quo — bringing fresh thinking and bold proposals to how PMS is designed and delivered, while maintaining full regulatory compliance. You're energized by change and motivated to reform existing approaches, not just maintain them. Regulatory and scientific foundation: Solid knowledge of Japan's Pharmaceutical and Medical Device Act (PMD Act) and GPSP, or meaningful hands-on experience in a GxP-regulated environment; able to apply scientific judgment within a compliance-first framework. Post-marketing surveillance expertise: 5+ years of experience in post-marketing surveillance and investigations, with a strong track record of leading end-to-end PMS programs across multiple products or therapeutic areas. Database research experience: Proven experience planning and conducting post-marketing database studies, with the ability to translate research objectives into scientifically sound study designs. Medical and regulatory writing: Demonstrated ability to prepare high-quality regulatory documents, study protocols, analysis plans, and scientific reports to a standard that meets regulatory authority expectations. Strategic thinking and results orientation: Ability to balance regulatory requirements with forward-thinking scientific judgment — setting clear direction, making sound decisions under complexity, and driving outcomes with accountability. Stakeholder influence and communication: Exceptional coordination and communication skills across functions and seniority levels, with the confidence to engage regulatory authorities and align diverse internal and global stakeholders. Project leadership: Strong organizational and task management capabilities, with the ability to oversee multiple complex workstreams simultaneously while maintaining quality, compliance, and timelines. Languages: Business-level English communication skills (written and verbal); Japanese fluency required. --- Why Choose Us? • Lead with purpose — take the helm of a team whose work directly protects patients, ensuring that every medicine we bring to market continues to meet the highest standards of safety and scientific integrity. • Shape regulatory strategy at the highest level — engage directly with regulatory authorities and influence how post-marketing surveillance is designed and executed across Sanofi's Japan portfolio. • Drive progress from within — help simplify, modernize, and elevate how a global biopharma business manages regulatory commitments, with the freedom to challenge convention and introduce smarter ways of working. • Make an impact across borders — collaborate with global teams and leaders, turning complex regulatory challenges into real-world solutions that benefit patients worldwide. • Advance your career through stretch leadership opportunities, cross-functional exposure, and development programs designed to match your ambition and grow your impact. • Thrive in an inclusive, high-performing environment where your leadership matters, your voice shapes what's next, and your team's success is supported by a culture of collaboration and shared purpose. • Enjoy a well-rounded rewards package — including flexible working options, comprehensive healthcare, and 14 weeks of gender-neutral parental leave. --- Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !