Global Core Labelling Strategy Lead

Regulatory Toolkit; Washington (District of Columbia); Presencial; USD 95 000 - 193 000; Tempo integral

Resumo da oferta

Mylan Inc. is seeking a Senior Manager, Core Labeling Strategy to lead global labelling development, maintenance, and compliance across a diverse product portfolio in support of regulatory submissions and lifecycle management.

The role requires strategic input to Target Product Labelling and coordination with Regulatory, Medical, Safety, and Commercial teams to ensure scientific accuracy and regulatory acceptability. Excellent leadership and communication are essential.

Qualificações

• Bachelor’s degree in Science, Medicine, Pharmacy, or related field with typically 7–10 years of experience, including significant labelling experience.
• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory labeling

Cross-functional collaboration

Project management

Communication

Leadership

Formação académica

Bachelor’s degree in Science/Medicine/Pharmacy

Advanced degree (MSc/PharmD/PhD) advantageous

Descrição da oferta de emprego

Mylan Inc. is seeking a Senior Manager, Core Labeling Strategy to lead global labelling development, maintenance, and compliance across a diverse product portfolio in support of regulatory submissions and lifecycle management.

The role requires strategic input to Target Product Labelling and coordination with Regulatory, Medical, Safety, and Commercial teams to ensure scientific accuracy and regulatory acceptability. Excellent leadership and communication are essential.