Benefits

ANZ leadership role with genuine strategic influence

Lead and develop an established Regulatory Affairs team

Broad exposure across new registrations, lifecycle management and portfolio growth

Join a growing healthcare business with an expanding portfolio and pipeline

About the company This established healthcare organisation operates across Australia and New Zealand, partnering with a broad range of products and businesses across the pharmaceutical sector. With continued growth across the region, the business offers a fast-moving and commercially focused environment where Regulatory Affairs plays an important role in portfolio strategy, new opportunities and successful product launches.

About the opportunity An exciting opportunity has become available for an experienced Regulatory Affairs leader to take responsibility for the ANZ regulatory function.

Leading a small team, you will oversee regulatory strategy and execution across Australia and New Zealand while remaining close to key submissions, new registrations and complex regulatory projects.

This is broader than a traditional Regulatory Affairs management position. You will work closely with senior leadership, commercial teams and external partners to assess new opportunities, shape regulatory strategy and provide guidance around pathways, timelines, risk and feasibility. The role would suit someone who enjoys leading people but still wants to remain connected to the technical and strategic side of Regulatory Affairs.

Duties

Lead, coach and develop the Regulatory Affairs team

Set priorities and oversee regulatory workload across the portfolio

Develop regulatory strategies for current product registrations and lifecycle activities

Provide oversight of submissions to the TGA and Medsafe

Support new registrations, variations,



transfers and post-approval activities

Lead complex or business-critical regulatory projects

Provide regulatory input into new product opportunities, portfolio expansion and business cases

Assess regulatory pathways, timelines, risks and resource requirements for prospective opportunities

Partner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business Development

Build strong relationships with external partners and provide strategic regulatory advice

Support regulatory aspects of product launches, manufacturing changes and artwork updates

Contribute to regulatory process improvement, compliance and inspection readiness

Monitor team resources, project requirements and regulatory service delivery

Contribute to broader ANZ leadership discussions and business planning

Skills and Experience

Extensive pharmaceutical Regulatory Affairs experience across the Australian market

Strong knowledge of TGA regulatory requirements and ideally experience across New Zealand/Medsafe

Demonstrated experience managing new registrations as well as ongoing lifecycle activities

Previous people leadership experience, including coaching and developing regulatory professionals

Comfortable remaining hands-on and providing technical guidance when required

Strong understanding of regulatory strategy and the commercial implications of regulatory decisions

Strong stakeholder management skills with the confidence to work with senior internal and external stakeholders

Able to manage multiple priorities within a changing and commercially focused environment

Proactive, solutions-focused and comfortable taking ownership

Culture Join a collaborative and agile environment where Regulatory Affairs has strong visibility across the wider business.

📌 Regulatory Affairs Manager ANZ (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney