Head of Global Labelling

CSL; Melbourne; On-site; AUD 240,000 - 360,000; Full time

Job summary

CSL Seqirus in Melbourne seeks Head of Global Labelling to lead the worldwide labelling function, reporting to Regulatory and chairing Global Labelling Committee.

You will shape strategy, oversee end-to-end review, collaborate with safety, development, commercial and supply chain, and drive timely regulatory updates.

This role requires director-level pharma experience and a proven ability to lead diverse teams across regions.

Qualifications

• Extensive experience in global regulatory affairs focused on product labelling.
• Proven leadership of multi-country teams.
• End-to-end ownership of regulated labelling processes.
• Experience presenting to governance bodies or regulators.
• Director-level experience in pharma/biotech.

Responsibilities

• Lead a global team of labelling professionals and own the end-to-end labelling review and approval process.
• Set global labelling strategy balancing business needs with benefit/risk information.
• Ensure timely updates and efficient operations for annual influenza strain changes.
• Advise governance bodies and auditors; interact with cross-functional stakeholders.

Skills

Global regulatory affairs

Labelling management

Leadership of global teams

Regulatory governance

Audit readiness

Job description

Head of Global Labelling

The Role

CSL Seqirus' influenza vaccine portfolio reaches millions of people every year, and every one of those products depends on labelling that's scientifically sound, regulatory compliant, and is clear and informative for the end-user. This role leads the function responsible for labelling globally — with a seat on the regulatory leadership team and as Chair of the Global Labelling Committee.

As Head of Global Labelling, you'll shape the strategic direction of labelling for Seqirus’ worldwide portfolio, reporting to the VP Regulatory Affairs & Pharmacovigilance. It's the point where clinicaldata, regulatory requirement, and commercial reality converge to ultimately define how a product is understood and used.

What You'll Be Responsible For

You'll lead a global team of established labelling professionals, coaching them in strategic thinking and the leadership behaviours Seqirus expects of its people — while owning the end-to-end labelling review and approval process and driving its continuous improvement.

You'll set global labelling strategy, balancing business need against the core obligation of getting benefit/risk information right for the people relying on it, and you'll ensure the underlying processes deliver accurate, timely labelling information that supports the safe and effective use of Seqirus’ products, importantly, including the regulatory requirements around timely safety-related updates.

Separately, you'll ensure efficient labelling operations support for the time-critical annual strain updates that seasonal influenza vaccines require.

Beyond the team, you'll provide labelling perspective to governance bodies, represent Seqirus' position in external regulatory forums, and provide labelling subject matter expertise for internal and external labelling-related audits. You'll work closely with cross-functional stakeholders including Global Safety, Clinical Development, Commercial and Supply Chain to ensure effective and timelylabelling deliverables meet business needs across every region Seqirus operates in.

Experience Required

• Significant experience in Global Regulatory Affairs, with a strong focus on product labelling and management of core labelling documentation.
• Proven leadership of global, multi-country teams, including coaching and developing talent.
• Track record owning and continuously improving a regulated process end-to-end.
• Experience representing a company's positions to governance bodies or external regulators.
• Working familiarity with labelling-related audits and the regulatory frameworks that govern labelling compliance.
• Director-level experience (or equivalent) in a global pharma or biotech organization.