Head of Global Labeling and Regulatory Policy
Pubblicato il 07-08-2026 - Altro in Italia
Head of Global Labeling and Regulatory Policy In this global role you will define and drive labeling strategies and regulatory policy for the Innovative Rx portfolio at Alfasigma. You will lead governance for core labeling data and ensure alignment with worldwide requirements to accelerate development and commercialization. You will shape policy through engagement with authorities and industry groups, while advancing digital labeling and data transformation. You will build and lead a cross‐functional team, fostering a ONE‐team culture focused on patients. This is a strategic opportunity to influence global labeling at scale and to enable innovative, compliant product delivery.
extensive opportunities for professional growth and development
Define and implement global labeling strategies for the Innovative Rx portfolio and manage governance like Global Labeling Committee
Monitor and translate global regulatory trends into internal policy and guidance
Oversee end‐to‐end labeling processes (CCDS, lifecycle updates) across products
Represent the company in interactions with health authorities, trade associations, and working groups
Drive adoption of digital labeling solutions (e‐labeling, structured content, IDMP/SPOR, UDI) and ensure data integrity
Establish global standards, SOPs, and governance to harmonize labeling/regulatory processes
Collaborate with Development, Quality, Safety, Supply Chain, Commercial, and Legal across product lifecycle
Lead and develop a high‐performing team with a One Team mindset to support patients and growth
10+ years in regulatory affairs or labeling in pharma or related fields
Strong knowledge of FDA, EMA, ICH frameworks
Proven experience in global labeling strategy and policy development
Experience leading cross‐functional, international teams
Strong leadership, influencing, and communication skills
Advanced degree in life sciences, pharmacy, regulatory affairs, or related field (PhD, PharmD, MSc preferred)
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