Manager, Core Labeling Strategy

Viatris•Columbia, WA

About The Position

Viatris is a global healthcare company that combines the strengths of generics and brands to address healthcare needs worldwide. With a mission to empower people to live healthier lives, Viatris supplies high-quality medicines to approximately 1 billion patients annually. The Manager, Core Labeling Strategy will provide global regulatory labeling expertise and leadership to ensure Product Information (labelling) for existing and new Viatris products is developed, maintained, and implemented in compliance with regulatory requirements. This role is responsible for the development and maintenance of Core Labelling, including the Core Company Data Sheet (CCDS) and associated patient information. It also supports Global Advertising & Promotion and Medical/Commercial material review and approval, and contributes to strategic labeling activities across the product lifecycle, such as Target Product Labelling (TPL), competitive labeling analysis, and regulatory precedent assessment to support global regulatory strategy and major submissions. All activities must be performed in accordance with applicable SOPs, regulatory requirements, and company policies.

Requirements

Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 3-5 years of 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).
Highly developed interpersonal, presentation and communication skills.
Ability to provide innovative approaches/recommendations to product labelling 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.
Carry out responsibilities in accordance with the organization's policies and applicable laws.

Nice To Haves

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 labelling benchmarking, and regulatory strategy support is an advantage.

Responsibilities

Supports management and delivery of labelling activities across assigned products/portfolio.
Contributes to 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.
Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives.
May contribute 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.
Performs other labelling-related duties as assigned.
Responsibilities may include training employees.