Head of Global Labeling

CSL

About The Position

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 clinical data, regulatory requirement, and commercial reality converge to ultimately define how a product is understood and used.

Requirements

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.

Responsibilities

Lead a global team of established labelling professionals, coaching them in strategic thinking and the leadership behaviours Seqirus expects of its people.
Own the end-to-end labelling review and approval process and drive its continuous improvement.
Set global labelling strategy, balancing business need against the core obligation of getting benefit/risk information right for the people relying on it.
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.
Ensure efficient labelling operations support for the time-critical annual strain updates that seasonal influenza vaccines require.
Provide labelling perspective to governance bodies.
Represent Seqirus' position in external regulatory forums.
Provide labelling subject matter expertise for internal and external labelling-related audits.
Work closely with cross-functional stakeholders including Global Safety, Clinical Development, Commercial and Supply Chain to ensure effective and timely labelling deliverables meet business needs across every region Seqirus operates in.