At a Glance
- Tasks: Lead global labelling strategy and manage a team of labelling professionals.
- Company: CSL Seqirus, a leader in influenza vaccine development.
- Benefits: Competitive salary, leadership opportunities, and a chance to make a global impact.
- Other info: Join a dynamic team with a focus on continuous improvement and innovation.
- Why this job: Shape the future of vaccine labelling and ensure safety for millions worldwide.
- Qualifications: Significant experience in Global Regulatory Affairs and proven leadership skills.
The predicted salary is between 135000 - 165000 $ per year.
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.
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Head of Global Labelling in Melbourne employer: CSL
CSL is an exceptional employer that fosters a collaborative and innovative work culture, making it a leader in the biotechnology sector. With a strong commitment to employee growth, CSL offers extensive professional development opportunities and the chance to work on impactful projects across the Asia Pacific region. Located in Australia, employees benefit from a supportive environment that values diversity and inclusion, ensuring a rewarding career path in a company dedicated to saving lives.
