At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility.
We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'.
There are so many reasons to join us.
If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Regulatory Affairs Manager Where do you want to go?
Are you a strategic Regulatory Affairs professional who thrives in a collaborative, empowered team environment?
At Bayer, we're driven by a vision to improve the lives of patients through innovation.
We're looking for an experienced Regulatory Affairs Manager to play a pivotal role in shaping regulatory strategy, driving successful product commercialisation, and ensuring continued compliance across our pharmaceutical portfolio in Australia and New Zealand.
This is an prospect to work at the intersection of science, innovation, and business, partnering with local and global stakeholders to deliver meaningful outcomes for patients, healthcare professionals, and healthcare systems.
The Opportunity As Regulatory Affairs Manager, you will lead the development and execution of regulatory strategies that support both pipeline and marketed products.
Working within an agile, cross-functional environment, you'll collaborate closely with Product Teams, Global Regulatory Affairs, Medical Affairs,
Market Access, Quality, Supply Chain, and external health authorities to bring innovative therapies to patients and maintain Bayer's licence to operate.
Your expertise will directly influence product approvals, lifecycle management, and regulatory policy engagement, helping shape the future of Bayer's pharmaceutical business in ANZ.
Do something that moves you.
Develop and execute regulatory strategies to support the registration, commercialisation, and lifecycle management of pharmaceutical products across Australia and New Zealand.
Lead regulatory submissions, variations, and health authority interactions to achieve timely approvals and maintain compliance.
Provide strategic regulatory guidance for pipeline and marketed products, identifying risks, opportunities, and mitigation plans to support business objectives.
Partner with cross-functional teams to support product launches, market access initiatives, labelling optimisation, and broader commercialisation strategies.
Build strong relationships with local, regional, and global stakeholders, acting as a trusted regulatory advisor across the business.
Monitor and interpret changes in the regulatory environment, translating requirements into practical business actions.
Ensure ongoing compliance with regulatory, GxP, and internal quality requirements while maintaining product licences and inspection readiness.
Drive operational excellence through continuous improvement of regulatory processes, systems, and ways of working.
Does this sound like you?
Essential Qualifications
📌 Regulatory Affairs Manager (Sydney)
🏢 Bayer
📍 Sydney