Head of Global Labelling

CSL; Waltham (MA); Vor Ort; USD 180.000 - 250.000; Vollzeit

Zusammenfassung

CSL Seqirus in Massachusetts seeks Head of Global Labelling to drive the international labelling strategy for its influenza vaccine portfolio. You will chair the Global Labelling Committee and sit on the regulatory leadership team, shaping how clinical data and regulatory requirements translate into clear, compliant labeling for end users.

You'll lead a global team, coach leaders, own the end-to-end labelling review and approval processes, and partner with Global Safety, Clinical Development,

Qualifikationen

• Extensive Global Regulatory Affairs experience focused on product labelling.
• Led global, multi-country teams; coaching and talent development.
• Owns and improves a regulated end-to-end process.
• Experience presenting positions to governance bodies or regulators.
• Familiar with labelling audits and regulatory frameworks.
• Director-level experience in global pharma/biotech.

Aufgaben

• 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 accuracy of benefit/risk information.
• Ensure timely safety-related updates regulatory requirements.
• Provide efficient operations support for annual strain updates in seasonal influenza vaccines.
• Advise governance bodies and represent Seqirus in external regulatory forums; collaborate with cross-functional teams.

Kenntnisse

Global RA leadership

Team leadership

Regulatory process

Regulatory audits

Cross-functional collaboration

Governance engagement

Jobbeschreibung

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.

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 clinical data, 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 timely labelling 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.