Global Regulatory Affairs Senior ManagerOn behalf of a multinational pharmaceutical group, Jefferson Wells Italia seeks a Global Regulatory Affairs Senior Manager to develop and execute global regulatory strategies that secure rapid approvals and advantageous labeling aligned with product characteristics and business needs.Main Responsibilities:Develop and implement the regulatory strategy for a product or product group, ensuring rapid approval and advantageous labeling that meets business, market, and patient needs.Collaborate with global and local functions to maintain product compliance, supply, and marketing activities.Deliver all regulatory milestones, including program approvability assessments and risk mitigation measures.Assess emerging data against project goals and update senior management on risks and mitigation activities.Define the regulatory development plan and own the construction of the global dossier and core prescribing information.Provide coaching and performance feedback to other regulatory staff working on the product/project.Lead regulatory leadership in product license‑in/due diligence review, product divestment, and product withdrawal.Qualifications:Scientific degree with consolidated experience in regulatory affairs roles within multinational pharmaceutical companies or CROs.Strong leadership capabilities with excellent knowledge of regulatory processes at the European and global level.Deep understanding of global lifecycle management dynamics and strong regulatory knowledge.Fluent English language skills.Company Overview: Multinational group focused on producing high‑quality medicinal specialties across therapeutic areas including cardiovascular, gastroenterology, gynecology, immunology, and rare diseases.Location: Milan area (office‑based).Employment Type: Permanent, full‑time.Compensation: Competitive base salary plus bonus and benefits.
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