CSL
Manager, Labelling Operations, Seqirus
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Manager, Global Labelling Operations (GLO)
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. This position is a key partner to Global Regulatory Affairs Regions and Supply Chain and plays a pivotal role in ensuring efficient labelling operations support for regulatory submissions and product supply, including time-critical annual strain updates for Seqirus’ seasonal influenza vaccines portfolio.
Main Responsibilities & Accountabilities
- Regulatory lead for the development, approval and maintenance of printed artwork for Seqirus’ marketed products globally.
- Collaborates 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.
- Provides tactical and strategic guidance to regional product labelling teams regarding placement and regulatory requirements for regional packaging component labelling content and design.
- Manages/inputs into process development, the establishment and maintenance of labelling systems, and compilation of performance and compliance metrics associated with labelling operations.
- Identifies and manages the implementation of operational improvements to ensure business excellence for Seqirus in all aspects of labelling operations.
- Provides operational training within Regulatory.
- Remains up to date with the global labeling requirements and expectations.
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Qualifications & Experience
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- University degree in Life Sciences or related pharmaceutical field.
- Ability to work in a rapid-paced environment.
- Biotech/pharmaceutical industry experience. This is inclusive of experience in labelling/regulatory combined with other global responsibility.
- Knowledge and understanding of principles 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/decisions.
- Must work well with others and within global teams, particularly cross-cultural exposure. Experience working in a complex and matrix environment is required.
- Excellent customer focus with demonstrated management of customer expectations and anticipating 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, coupled with the ability to think strategically.
- Fluency in English (verbal and written).
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