Manager, Labeling Operations

Job Overview  The Manager, Global Labelling Operations (GLO) is part of a team of labelling professionals responsible for managing and executing the technical and operational elements that support the development, review and approval of product packaging components globally to meet business objectives. In this role the manager ensures efficient labelling operations support for regulatory submissions and product supply, including time‑critical annual strain updates for Seqirus’ seasonal influenza vaccines portfolio.
Responsibilities   Regulatory lead for the development, approval and maintenance of printed artwork for Seqirus’ marketed products globally.
Collaborate with key stakeholders within regulatory affairs and other parts of the business (e.g. Commercial, Supply Chain, Quality Assurance, Project Management) to ensure timely development of artworks for regulatory submissions, in compliance with GMP.
Provide tactical and strategic guidance to regional product labelling teams regarding placement and regulatory requirements for regional packaging component labelling content and design.
Manage or input into process development, the establishment and maintenance of labelling systems, and compile performance and compliance metrics associated with labelling operations.
Identify and implement operational improvements to ensure business excellence in all aspects of labelling operations.
Provide operational training within regulatory.
Remain up to date with global labeling requirements and expectations.
Qualifications & Experience   University degree in Life Sciences or a related pharmaceutical field.
Ability to work in a rapid‑paced environment.
Experience in the biotech/pharmaceutical industry, including labelling/regulatory combined with other global responsibilities.
Knowledge and understanding of regulatory requirements relevant to drug development, global labelling and post‑marketing requirements.
Demonstrated problem‑solving ability, able to analyze risk and make appropriate recommendations and decisions.
Strong teamwork skills with global, cross‑cultural exposure.
Experience working in a complex, matrix environment.
Excellent customer focus with demonstrated management of customer expectations and anticipation of customer needs.
Organizational skills to interact seamlessly with stakeholders on regulatory compliance matters.
Effective verbal and written communication skills in a cross‑functional environment.
Attention to detail and ability to think strategically.
Fluency in English (verbal and written).
CSL is an Equal Opportunity Employer.

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