Global Regulatory Affairs Senior Manager

Jefferson Wells Italia; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A multinational pharmaceutical group is seeking a Global Regulatory Affairs Senior Manager in the Milan area. The role involves developing and executing global regulatory strategies, ensuring rapid approvals, and collaborating with various functions to maintain compliance. Candidates should possess a scientific degree and substantial experience in regulatory affairs within the pharmaceutical industry, along with strong leadership abilities and fluent English skills. This is a permanent, full-time position with competitive salary and benefits.

Servizi

Competitive base salary

Bonus

Benefits

Competenze

• Consolidated experience in regulatory affairs roles within multinational pharmaceutical companies or CROs.
• Excellent knowledge of regulatory processes at the European and global level.
• Deep understanding of global lifecycle management dynamics.

Mansioni

• Develop and implement the regulatory strategy for a product or product group.
• Collaborate with global and local functions to maintain product compliance.
• Deliver all regulatory milestones, including program approvability assessments.
• Assess emerging data against project goals and update senior management.
• Define the regulatory development plan and own the global dossier.
• Provide coaching and performance feedback to other regulatory staff.
• Lead regulatory leadership in product license-in/due diligence review.

Conoscenze

Leadership

Regulatory knowledge

Fluent English

Formazione

Scientific degree

Descrizione del lavoro

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.