Strategic Regulatory Lead — ANZ Pharma

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

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.