Senior Labeling Hub Manager

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 90 000 - 120 000; Tempo integral

Resumo da oferta

Viatris in Lisbon is seeking a Senior Labeling Hub Manager to lead regional labeling activities for generics and brands, developing strategies and ensuring regulatory compliance across Europe.

You will manage a regional team, provide SME support to the Global Labelling Operations Director, drive CCDS reviews, and coordinate with Launch Management, Supply Chain and Quality to deliver timely labeling updates.

Qualificações

• 5+ years of experience in product labeling and labeling development.
• 3+ years of leadership experience, including managing teams or leading cross-functional initiatives.
• 3+ years of regulatory affairs and/or project management experience with labeling expertise.

Responsabilidades

• Lead cross-functional teams in global labeling projects while ensuring regulatory alignment.
• Manage regional labeling team members, set objectives, and conduct reviews.
• Provide strategic regulatory guidance for generic and branded labeling based on policies and regulations.
• Review CCDS documentation and determine labeling updates as needed.
• Ensure timely labeling updates and liaise with legal on labeling content.
• Support health authority interactions and prepare labeling documents for submission.

Conhecimentos

Labeling experience

Leadership

Regulatory affairs

Project management

Communication

Pharma industry

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.

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 a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.