Senior Manager, Core Labelling Strategy (12 month agency contract)

Benefits

Additional Information

McDermott Laboratories Limited 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. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Provide global regulatory labelling expertise and leadership to ensure Product Information (labelling) for both existing and new Viatris products is developed, maintained, and implemented in compliance with applicable regulatory requirements. The role is responsible for the development and maintenance of Core Labelling (including CCDS and associated patient information) and supports Global Ad Promo and Medical/Commercial material review and approval in line with company principles and procedures. Additionally, the role contributes to strategic labelling activities across the product lifecycle, including Target Product Labelling (TPL), competitive labelling analysis, and regulatory precedent assessment to support global regulatory strategy and major submissions (e.g. USPI, EU SmPC). All activities are performed in accordance with applicable SOPs, regulatory requirements, and company policies. Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Core Labelling Strategy role will make an impact: Accountable for management and delivery of labelling activities across assigned products/portfolio. Leads development, preparation, review, and approval of global labelling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labelling (e.g. EU SmPC, USPI) based on clinical and non-clinical data. Leads or supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives. Contributes to development and maintenance of Target Product Labelling (TPL) to support early development, regulatory positioning, and cross-functional alignment. Establishes strong cross-functional partnerships with Regulatory Strategists, Medical, Safety, and Clinical teams to ensure proactive and effective labelling development. Leads labelling updates and development, critically evaluating supporting data to ensure scientific accuracy, clinical relevance, and regulatory acceptability. Assesses and reconciles deviations from Company Core Position (e.g. CCDS) and supports responses to Health Authority requests. Chairs or actively contributes to Product Labelling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required. Maintains strong awareness of competitor labelling, evolving regulatory requirements, and external trends to inform labelling strategy. Manages complex regulatory and scientific labelling issues, balancing compliance, business needs, and risk. Contributes to interpretation and application of emerging regulatory guidelines impacting labelling. May represent Viatris in external forums (e.g. industry groups, EMA/FDA workshops). Reviews and approves promotional and non-promotional materials for alignment with CCDS and applicable codes and requirements. Reviews and advises on key scientific and regulatory documents (e.g. IB, protocols, CSR, PSURs, RMPs) as appropriate. Provides labelling expertise in cross-functional and regulatory team discussions. About Your Skills & Experience For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Bachelor's degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically experience, including significant labelling experience. Demonstrated experience in development and maintenance of global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC). Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred. Advanced degree (MSc, PharmD, PhD) is advantageous

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