Senior Labeling Hub Manager

Biopharma Careers; Lisboa; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

Viatris seeks a Senior Labeling Hub Manager in Lisbon, Portugal, to lead global labelling projects for generic and branded products, ensuring regulatory alignment and timely delivery.

You will manage regional labeling teams, provide SME input to the Global Labelling Operations Director, and shape labeling strategies across CCDS interpretations, artwork interfaces, and health authority interactions.

Qualificações

• 5+ years of experience in product labeling and labeling development.
• 3+ years of leadership experience managing teams and/or leading cross-functional initiatives.
• 3+ years of regulatory affairs and/or project management experience with labeling expertise.
• Experience with electronic submission systems such as Lorenz or equivalent.
• Experience with change control systems such as TrackWise or equivalent.

Responsabilidades

• Lead cross-functional teams in global labelling projects, ensuring alignment with regulatory requirements and company objectives.
• Manage and lead the regional labelling team members including setting objectives, mid-year and end-year reviews, and ensure training and coaching to meet objectives.
• Communicate issues and resolutions clearly to peers and subordinates.
• Ensure accurate and timely labelling updates according to procedures and objectives.
• Support regional labelling team members with health authority questions and preparation/review of labelling documents.
• Advise Core Labelling Operations Director regarding deficiencies or issues.
• Provide regulatory guidance for generic and branded labelling based on policies and regulations.
• Review CCDS data and determine labelling updates accordingly.
• Coordinate with Product Labelling Team and Global Labelling Committee.

Conhecimentos

Labeling

Leadership

Regulatory Affairs

Project Management

Cross-functional

Ferramentas

Lorenz

TrackWise

Descrição da oferta de emprego

Mylan, Lda.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Position Title:

Senior Labeling Hub Manager

Location:

Lisbon, Portugal

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Senior Labeling Hub Manager role will make an impact:

Develop labelling strategies, project plans and execute project plans in support of label creation and updates in accordance with specific timelines. Manage and lead regional labelling team members who support Pan European labelling activities for generic products and branded products as well as end to end labelling to artwork implementation.

Provide Subject Matter Expert support to the Global Labelling Operations Director, and other stakeholders, with initiatives which impact, or may impact, labelling activities within the European Economic Area.

Key responsibilities for this role include:

• Lead cross-functional teams in global labelling projects, ensuring alignment with regulatory requirements and company objectives.
• Manage and lead the regional labelling team members including setting objectives, mid-year and end-year reviews, and ensure training, development and coaching of team members is in place in order that they meet the team and individual objectives.
• Communicate clearly issues and resolutions to peers and subordinates in a meaningful way.
• Ensure accurate and timely labelling updates according to agreed company procedures and objectives.
• Support regional labelling team members with health authority questions, requests for further information, preparation and review of labelling documents prior to submission.
• Advise Core Labelling Operations Director regarding any deficiencies or issues.
• Provide strategic regulatory guidance/strategy for generic and branded labelling for new, pending and approved dossiers based on interpretation of policies, guidances and regulations.
• Ability to review and assess Company Core Data Sheets (CCDS) and make determination of labelling updates based on CCDS documentation.
• Ability to clearly communicate labelling topics to members of the Product Labelling Team and Global Labelling Committee.
• General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
• Ensure compliance with end-to-end labelling to artwork implementation.
• Liaise with the legal department regarding labelling content based on patent and exclusivity information.
• Maintain a high level of knowledge of all regional laws, regulations and guidances. Ensure timely implementation of new requirements.
• Participate in audits, both internal and external, as needed.

What you’ll bring for this role:

• 5+ years of experience in product labeling and labeling development.
• 3+ years of leadership experience, including managing teams and/or leading cross-functional initiatives.
• 3+ years of regulatory affairs and/or project management experience with extensive labeling expertise.
• Strong interpersonal, presentation, and communication skills with the ability to influence stakeholders across functions.
• Demonstrated ability to develop innovative labeling solutions while ensuring compliance with applicable regulatory requirements.
• Experience in the pharmaceutical, biotechnology, or healthcare industry.
• Experience with electronic submission systems such as Lorenz or equivalent.
• Experience with change control systems such as TrackWise® or equivalent.
• Knowledge of document control and document management systems.
• Experience working in a global and cross-functional environment.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

A t Viatris, we offer competitive salar ies , benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.