Global Labelling Director — Strategy & Compliance

CSL; Waltham (MA); Presencial; USD 180 000 - 250 000; Tempo integral

Resumo da oferta

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,

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Global RA leadership

Team leadership

Regulatory process

Regulatory audits

Cross-functional collaboration

Governance engagement

Descrição da oferta de emprego

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,