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.
Qualifications & Experience
- 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)
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
Skills Required
- University degree in Life Sciences or related field
- Degree in a pharmaceutical field (e.g., Chemistry, Engineering)
- Advanced degree (MSc, PhD, PharmD)
- Biotech/pharmaceutical industry experience, including labeling/regulatory with global responsibility
- Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing
- Demonstrated problem-solving ability and risk analysis for decision making
- Experience working in complex, matrixed global teams with cross-cultural exposure
- Organizational skills for interacting on regulatory compliance matters internally and externally
- Effective communication skills to explain concepts, options, and impacts
- Fluency in English (verbal and written)
What We Do
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
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