Senior Manager, Core Labeling Strategy
Viatris, Washington, District of Columbia, United States
Senior Manager, Core Labeling Strategy
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. Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Core Labeling Strategy will make an impact: Provide global regulatory labeling expertise and leadership to ensure Product Information (labeling) 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 Labeling (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 labeling activities across the product lifecycle, including Target Product Labeling (TPL), competitive labeling 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. Key responsibilities for this role include: Accountable for management and delivery of labeling activities across assigned products/portfolio. Leads development, preparation, review, and approval of global labeling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labeling (e.g. EU SmPC, USPI) based on clinical and non-clinical data. Leads or supports development of labeling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives. Contributes to development and maintenance of Target Product Labeling (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 labeling development. Leads labeling 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 Labeling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required. Maintains strong awareness of competitor labeling, evolving regulatory requirements, and external trends to inform labeling strategy. Manages complex regulatory and scientific labeling issues, balancing compliance, business needs, and risk. Contributes to interpretation and application of emerging regulatory guidelines impacting labeling. 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 labeling expertise in cross-functional and regulatory team discussions. Performs other labeling-related duties as assigned. The minimum qualifications for this role are: Bachelor's degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 710 years of experience, including significant labeling experience. Demonstrated experience in development and maintenance of global core labeling (e.g. CCDS) and major market labeling (e.g. USPI, EU SmPC). Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred. Advanced degree (MSc, PharmD, PhD) is advantageous but not required. Experience in TPL development, competitive labeling benchmarking, and regulatory strategy support is an advantage. Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labeling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment Position functions autonomously. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD. 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.
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. Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Core Labeling Strategy will make an impact: Provide global regulatory labeling expertise and leadership to ensure Product Information (labeling) 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 Labeling (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 labeling activities across the product lifecycle, including Target Product Labeling (TPL), competitive labeling 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. Key responsibilities for this role include: Accountable for management and delivery of labeling activities across assigned products/portfolio. Leads development, preparation, review, and approval of global labeling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labeling (e.g. EU SmPC, USPI) based on clinical and non-clinical data. Leads or supports development of labeling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives. Contributes to development and maintenance of Target Product Labeling (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 labeling development. Leads labeling 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 Labeling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required. Maintains strong awareness of competitor labeling, evolving regulatory requirements, and external trends to inform labeling strategy. Manages complex regulatory and scientific labeling issues, balancing compliance, business needs, and risk. Contributes to interpretation and application of emerging regulatory guidelines impacting labeling. 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 labeling expertise in cross-functional and regulatory team discussions. Performs other labeling-related duties as assigned. The minimum qualifications for this role are: Bachelor's degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 710 years of experience, including significant labeling experience. Demonstrated experience in development and maintenance of global core labeling (e.g. CCDS) and major market labeling (e.g. USPI, EU SmPC). Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred. Advanced degree (MSc, PharmD, PhD) is advantageous but not required. Experience in TPL development, competitive labeling benchmarking, and regulatory strategy support is an advantage. Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labeling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment Position functions autonomously. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD. 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.