Regulatory Affairs Manager

Health and Aged Care Professionals; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Leadership role

Team leadership

Regulatory exposure

Career growth

Job summary

Health and Aged Care Professionals in Sydney seeks an experienced Regulatory Affairs leader to oversee ANZ regulatory strategy and execution. Leading a small team, you will shape registration pathways, lifecycle activities and strategic opportunities across Australia and New Zealand.

You will work closely with senior leadership, Commercial, Quality and external partners to deliver submissions, risk assessments and timelines, while staying hands-on with technical guidance and regulatory advice.

Qualifications

• 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.

Responsibilities

• Lead, coach and develop the Regulatory Affairs team.
• Set priorities and oversee regulatory workload across the portfolio.
• Develop regulatory strategies for new 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

Regulatory affairs

TGA

Medsafe

Regulatory strategy

Stakeholder management

People leadership

Job description

Health and Aged Care Professionals - Sydney NSW

Full time

19d ago , from Health and Aged Care Professionals

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 new 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.