Global Labelling Director - Strategy & Compliance

Regulatory Toolkit; Waltham (MA); Presencial; USD 250 000 - 350 000; Tempo integral

Resumo da oferta

CSL Seqirus is seeking a Head of Global Labelling to lead the global labelling function, sit on the regulatory leadership team, and chair the Global Labelling Committee. Reporting to the VP Regulatory Affairs & Pharmacovigilance, the role shapes strategy for Seqirus’ influenza vaccine portfolio.

You will manage a global team, own end-to-end labelling reviews, drive improvements, ensure timely safety-related updates, and collaborate with Global Safety, Clinical Development, Commercial and Supply

Qualificações

• Significant experience in Global Regulatory Affairs with a focus on product labelling and documentation.
• Proven leadership of global, multi-country teams and talent development.
• Experience owning and improving regulated processes end-to-end.
• Experience representing positions to governance bodies or regulators.
• Familiarity with labelling audits and regulatory frameworks.
• Director-level experience in global pharma/biotech.

Responsabilidades

• Lead a global team of labelling professionals and drive end-to-end labelling review and approval.
• Set global labelling strategy and ensure accurate, timely labelling information.
• Represent Seqirus in governance bodies and external regulatory forums.
• Collaborate with Global Safety, Clinical Development, Commercial and Supply Chain.

Conhecimentos

Global regulatory affairs

Leadership

Regulatory governance

Labelling strategy

Cross-functional collaboration

Descrição da oferta de emprego

CSL Seqirus is seeking a Head of Global Labelling to lead the global labelling function, sit on the regulatory leadership team, and chair the Global Labelling Committee. Reporting to the VP Regulatory Affairs & Pharmacovigilance, the role shapes strategy for Seqirus’ influenza vaccine portfolio.

You will manage a global team, own end-to-end labelling reviews, drive improvements, ensure timely safety-related updates, and collaborate with Global Safety, Clinical Development, Commercial and Supply