Sr. Manager - Core Labelling Strategy Team || Remote

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.
• Performs other labelling-related duties as assigned.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE

• Regulatory experience with strong knowledge of global labelling across development and lifecycle management.
• Understanding of PLT and GLC governance frameworks and EU/US labelling requirements (SmPC, USPI, CCDS).
• Experience with TPL development and competitive labelling analysis.
• Experience supporting labelling for regulatory submissions in major markets (e.g. US, EU).
• Prior leadership experience or demonstrated ability to lead and influence others in a matrix environment.

SKILLS AND ABILITIES

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

EDUCATION/EXPERIENCE

• Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 7–10 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).
• 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