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Head of Global Labeling
Head of Global Labelling
About the Role
CSL Seqirus' influenza vaccine portfolio reaches millions of people every year. Each product relies on labelling that is scientifically sound, regulatory compliant, and clear and informative for the end user.
As Head of Global Labelling, you will lead the function responsible for global labelling, including a seat on the regulatory leadership team and as Chair of the Global Labelling Committee. Your reporting line will be to the Vice President of Regulatory Affairs & Pharmacovigilance.
Your role sits at the intersection of clinical data, regulatory requirements, and commercial realities — determining how a product is understood and used by its intended audiences.
What You'll Be Responsible For
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Strategic leadership:
- Shape the global labelling strategy to align with business needs and risk/benefit obligations, ensuring safe and effective product use and compliance with regulatory timelines.
- Develop and refine the end-to-end labelling review and approval process, driving its continuous improvement.
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Team management:
- Lead an established global team of labelling professionals, fostering strategic thinking and leadership behaviours in line with Seqirus' values while developing team talent.
- Ensure efficient labelling operations to support the urgent annual strain updates for seasonal vaccines.
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Regulatory engagement:
- Provide labelling strategy and expertise to relevant governance bodies, representing Seqirus in external regulatory forums.
- Contribute to and supervise internal and external labelling audits, ensuring compliance with regulatory frameworks.
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- Cross-functional collaboration:
- Work closely with Global Safety, Clinical Development, Commercial, and Supply Chain to ensure timely and effective labelling, fulfilling Seqirus' needs across all regions.
Experience Required
- Expertise in Global Regulatory Affairs with a proven focus on product labelling and core labelling documentation.
- Leadership track record in managing global, multi-country teams, including coaching, developing, and motivating talent.
- End-to-end process ownership with a proven ability to continuously improve regulated processes.
- Regulatory representation experience, including presenting a company's perspective to internal/external governance, regulators, and regulating authorities.
- Familiarity with labelling-related audits and the regulatory frameworks governing labelling compliance.
- Director-level (or equivalent) experience in a global pharma or biotech organisation.
About CSL Seqirus
CSL Seqirus is a division of CSL, one of the world’s largest influenza vaccine providers. Their mission revolves around preventing influenza globally and preparing for pandemics. With cutting-edge production facilities in the U.S., the U.K., and Australia, CSL Seqirus uses egg, cell, and adjuvant technologies to deliver a broad portfolio of differentiated influenza vaccines in over 20 countries.
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Visit CSL for more information.
Our Benefits For details on benefits offered by CSL, visit [How CSL Supports Your Well-Being](How CSL Supports Your Well-being | CSL).
Why You Belong at CSL
Inclusion and Belonging at CSL
At CSL, Inclusion and Belonging permeates the company’s mission and operational culture. This principle drives innovation and fosters an environment characterized by:
- Celebrating differences
- Promoting curiosity and empathy
This collaborative approach allows CSL to better understand and connect with patients and donors, forge strong stakeholder relationships, and maintain a diverse workforce pushing CSL into the future.
For more information, see CSL’s Inclusion and Belonging page.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. They ensure accommodations are provided for individuals with disabilities during applicant interviews and throughout the application process. Additional information is available on CSL's Accessibility Statement.
For recruitment-related queries, further Live on the Front Line video content is available on CSL Seqirus’ [YouTube/recruitment resources](specific video not explicitly linked).
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