Regulatory Affairs Manager

Bayer; Ku-ring-gai; On-site; AUD 140,000 - 210,000; Full time

Job summary

Bayer in Australia and New Zealand is seeking a Regulatory Affairs Manager to shape regulatory strategy, drive product approvals, and ensure ongoing compliance across the portfolio.

You will lead regulatory submissions, interact with health authorities, and collaborate with cross-functional teams to support launches and lifecycle management, while keeping pace with evolving global requirements.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline.
• 7-10 years' Regulatory Affairs experience within the pharmaceutical industry.
• Demonstrated success managing major regulatory submissions and health authority interactions across multiple application types, including new products and new indications.
• Strong understanding of Australian and New Zealand regulatory frameworks for medicines.
• Advanced knowledge of drug development, clinical data interpretation, CMC requirements, clinical research, and pharmacovigilance.
• Experience building productive cross-functional partnerships and influencing stakeholders at all levels.

Responsibilities

• 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.

Job description

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, then you've found the perfect place to nurture your aspirations and make an impact.

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 opportunity 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 & Experience

Bachelor's degree in Life Sciences, Pharmacy, or a related discipline.

7-10 years' Regulatory Affairs experience within the pharmaceutical industry.

Demonstrated success managing major regulatory submissions and health authority interactions across multiple application types, including new products and new indications.

Strong understanding of Australian and New Zealand regulatory frameworks for medicines.

Advanced knowledge of drug development, clinical data interpretation, CMC requirements, clinical research, and pharmacovigilance.

Experience building productive cross-functional partnerships and influencing stakeholders at all levels.

Highly Regarded

Master's degree in a relevant scientific discipline.

Experience supporting innovative therapies, including Advanced Therapy Medicinal Products (ATMPs).

Exposure to regulatory processes in the US and EU markets.

Experience partnering with Market Access teams on reimbursement and funding submissions.

What You'll Bring

Strategic thinking and strong business acumen.

Excellent communication and stakeholder management skills.

Ability to navigate ambiguity and manage competing priorities.

A proactive and solution-oriented mindset.

Passion for innovation and improving patient outcomes.

A commitment to collaboration, continuous learning, and inclusive leadership.

You @ Bayer

We are committed to creating a culture where people can be their best, in an environment that values inclusion, diversity and flexibility. At Bayer everyone belongs, regardless of race, colour, ancestry, religion, national origin, citizenship, sexual orientation, age, marital status, disability, gender identity, personality, thinking styles or background. We strongly encourage First Nations people to apply.

If you have a disability or special need that requires accommodation, please let us know.

Be part of something bigger

At Bayer we support your career. For more information about this role and the innovative suite of benefits on offer, get in contact with our Talent Acquisition Team via********@bayer.com.