**About the job** As a Regulatory Affairs Project Manager within our Regulatory Affairs team, you’ll lead and coordinate cross-functional regulatory projects across Australia and New Zealand. You’ll manage strategic submissions, compliance initiatives, and transversal projects that impact the entire Sanofi portfolio. Based in Macquarie Park, this is a high-impact role with visibility across the business. **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 execute regulatory submissions and lifecycle management across ANZ + Coordinate transversal projects with regulatory impact across the business + Manage vendor relationships, training, and budget oversight + Develop strategic regulatory approaches aligned with business goals + Ensure regulatory compliance and audit readiness + Represent Sanofi in industry groups and regulatory consultations + Monitor regulatory changes and communicate impacts to stakeholders **About you** **You bring proven experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of regulatory frameworks across Australia and New Zealand, as well as global standards. Your track record includes successful engagement with regulators and cross-functional teams, demonstrating strategic thinking and leadership capabilities. You’re skilled in stakeholder management, communication, and presentation, and proficient in Microsoft Office and regulatory systems and overall, you thrive in managing complex projects and driving outcomes.** **Why choose us?** + Be part of a pioneering biopharma company where patient insights shape drug development + Work at the forefront of AI-powered science that accelerates discovery and improves outcomes + Explore bold career paths – with opportunities to grow through scientific, leadership, and cross-functional moves + Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks’ gender-neutral parental leave + Lead impactful projects with visibility across the Sanofi portfolio + Collaborate with a high-performing, purpose-driven team in a globally connected environment 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)