Global Labelling Director – Regulatory Strategy

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

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