Head of Global Labelling

CSL Plasma Inc.; Maidenhead; On-site; GBP 150,000 - 190,000; Full time

Job summary

CSL Seqirus, a leading influenza vaccine provider with a global footprint, seeks a Head of Global Labelling to shape regulatory labelling across the worldwide portfolio. The role offers strategic leadership on the committee and regulatory interactions, driving timely safety information and updates.

The position sits on the Regulatory Leadership Team and partners with Global Safety, Clinical Development, Commercial and Supply Chain to ensure compliant, clear labelling for end-users across

Qualifications

• 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 leadership behaviours while owning end-to-end labelling review and approval processes.
• Set global labelling strategy, balancing business needs with ensuring accurate benefit/risk information and timely safety-related updates.
• Ensure efficient labelling operations support for time-critical annual strain updates in seasonal vaccines.
• Provide labelling perspective to governance bodies and represent Seqirus in external regulatory forums.
• Collaborate with cross-functional stakeholders to deliver labelling deliverables meeting regional business needs.

Skills

Global Regulatory Affairs

Labelling

Leadership

Governance

Cross-functional collaboration

Regulatory strategy

Education

Director-level experience in global pharma/biotech

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 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 will 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 will 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 will 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.
• You will ensure efficient labelling operations support for the time-critical annual strain updates that seasonal influenza vaccines require.
• Beyond the team, you will 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 will 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.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

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At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer CSL is an Equal Opportunity Employer.

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