Head of Global Labelling

Head of Global Labelling

CSL Seqirus' influenza vaccine portfolio reaches millions of people every year, and every product depends on labelling that is scientifically sound, regulatory compliant, and clear and informative for the end user.

This position leads the global labelling function, sits on the regulatory leadership team, and chairs the Global Labelling Committee. The Head of Global Labelling shapes the strategic direction of labelling for the worldwide portfolio and reports to the VP of Regulatory Affairs & Pharmacovigilance.

What You'll Be Responsible For

• Lead a global team of labelling professionals, coaching them in strategic thinking & leadership behaviours
• Own the end to end labelling review and approval process and drive continuous improvement
• Set global labelling strategy, balancing business needs with the core obligation of providing accurate benefit/risk information
• Ensure timely safety related updates and support time critical annual strain updates for seasonal influenza vaccines
• Provide labelling perspective to governance bodies and represent Seqirus in external regulatory forums
• Offer subject matter expertise for internal and external labelling related audits
• Collaborate with cross functional stakeholders (Global Safety, Clinical Development, Commercial & Supply Chain) to deliver effective and timely labelling that meets regional business needs

Experience Required

• Significant experience in global regulatory affairs with a strong focus on product labelling and core labelling documentation
• Proven leadership of global, multi country teams, with experience coaching and developing talent
• Track record of owning and continuously improving a regulated process end to end
• Experience representing a company's positions to governance bodies or external regulators
• 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

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit