Head of Global Labeling and Regulatory Policy (Italia)

Head of Global Labeling and Regulatory Policy (Italia)

01 ago
|
ALFASIGMA
|
Italia

01 ago

ALFASIGMA

Italia

Scope of the roleThis position is responsible for defining and driving global strategies for product labeling and regulatory policy across the company. Se le sue competenze, la sua esperienza e le sue qualifiche corrispondono a quelle descritte in questa panoramica, non ritardi l'invio della sua candidatura. This role ensures that product information, labeling content, and regulatory frameworks align with global requirements while enabling timely product development and commercialization.Your roleGlobal Labeling Strategy & Governance: Lead the development and implementation of global labeling strategies for the Innovative Rx portfolio and implement governance (e.g. Global Labeling Committee) to manage changes to Company Core Data Sheets (CCDS) etc.Regulatory Policy Leadership: Monitor, interpret, and influence evolving global regulatory frameworks; translate regulatory trends into actionable policies and guidance for internal stakeholders across multiple product categories.Label Development & Lifecycle Management: Oversee end-to-end labeling processes for Innovative Rx portfolio,



including CCDSs, and lifecycle updates (e.g., safety changes, new indications, reformulations).Health Authority & Industry Engagement: Represent the organization in interactions with global regulatory authorities, industry associations, and working groups to shape policy and stay ahead of regulatory changes.Digital Labeling & Data Transformation: Drive the adoption of digital labeling solutions (e.g., e-labeling, structured content, IDMP/SPOR, UDI), ensuring data integrity, standardization, and system integration.Operational Excellence & Process Harmonization: Establish global standards, SOPs, and governance models to streamline labeling and regulatory processes across regions and product types.Stakeholder Management: Partner with Development, Quality, Safety, Supply Chain, Commercial, and Legal to ensure alignment across the product lifecycle.Leadership: Drive the spirit of "ONE Team" acro

📌 Head of Global Labeling and Regulatory Policy (Italia)
🏢 ALFASIGMA
📍 Italia

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