Global Regulatory Affairs Senior Manager

Global Regulatory Affairs Senior Manager

On 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.