Global Labelling Director

CSL Seqirus; Thatcham; On-site; GBP 150,000 - 190,000; Full time

Job summary

CSL Seqirus seeks a Head of Global Labelling to lead the worldwide labelling function and sit on the regulatory leadership team. The role chairs the Global Labelling Committee and shapes strategic direction for labelling across the influenza vaccine portfolio.

Reporting to the VP Regulatory Affairs & Pharmacovigilance, the incumbent will align clinical data, regulatory requirements and commercial realities to produce clear, compliant labelling that informs end-users while meeting timely

Qualifications

• Significant experience in Global Regulatory Affairs with a strong focus on product labelling.
• Proven leadership of global, multi-country teams with coaching capability.
• Track record owning and continuously improving a regulated, end-to-end process.
• Experience representing a company's positions to governance bodies or external regulators.
• Working familiarity with labelling audits and regulatory frameworks governing compliance.
• Director-level experience (or equivalent) in a global pharma/biotech organization.

Responsibilities

• Lead a global team of labelling professionals and coach strategic thinking and leadership behaviours.
• Own end-to-end labelling review and approval processes and drive continuous improvement.
• Set global labelling strategy balancing business needs with accurate safety and benefit/risk information.
• Ensure timely labelling updates and support annual strain updates for seasonal vaccines.
• Provide labelling perspective to governance bodies and regulators; support audits.
• Collaborate with Global Safety, Clinical Development, Commercial and Supply Chain across regions.

Skills

Global Regulatory Affairs

Leadership

Regulatory process management

Regulatory audits

Stakeholder collaboration

Job description

CSL Seqirus seeks a Head of Global Labelling to lead the worldwide labelling function and sit on the regulatory leadership team. The role chairs the Global Labelling Committee and shapes strategic direction for labelling across the influenza vaccine portfolio.

Reporting to the VP Regulatory Affairs & Pharmacovigilance, the incumbent will align clinical data, regulatory requirements and commercial realities to produce clear, compliant labelling that informs end-users while meeting timely