ITALY - Legal & Compliance Manager

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands‑on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.

We are looking for a highly motivated Legal & Compliance Manager with a strong legal background and proven experience in a similar role to join our organization.

Celltrion Healthcare Italy is a fast‑growing company with a robust and diversified product pipeline across multiple therapeutic areas.

The ideal candidate has at least 5 years of experience in senior Legal & Compliance roles, preferably within the pharmaceutical or healthcare sector. Strong expertise in pharmaceutical regulations, corporate governance, anti‑corruption frameworks, and risk management are required.

Attitude is a key driver in our selection process: we are seeking a professional with strong interpersonal and leadership skills. The ideal candidate is proactive, pragmatic, flexible, and solution‑oriented, with a high level of integrity and sound judgment. An energetic, results‑driven mindset and strong motivation to contribute to the Company's sustainable growth, while growing professionally with Celltrion Healthcare Italy, are essential.

Key Responsibilities

• Privacy / GDPR: Ensure full compliance with data protection laws and oversee data governance practices.
• 231/01: Implement and monitor the Organizational Model pursuant to Legislative Decree 231/2001.
• Risk Assessment: Conduct periodic compliance risk assessments and define mitigation plans.
• OdV: Support and coordinate activities of the Supervisory Body.
• Sunshine Act: Ensure transparency reporting and disclosure of transfers of value.
• Audit: Lead internal compliance audits and manage corrective action plans.
• SOPs: Develop, update, and monitor Standard Operating Procedures.
• Internal Processes & Procedures: Design and strengthen internal controls and governance frameworks.
• Contract Drafting/Reviewing: Draft, review, and negotiate corporate agreements.
• General Legal Support: Provide day‑to‑day legal advice to all internal departments.
• Debt Collection: Oversee recovery actions and manage outstanding receivables.
• Disputes Management: Handle pre‑litigation matters and coordinate external counsel in litigation cases.
• Support for: Regulatory, Quality, AIFA Relations, CRO.

Essential Requirements

• from 5 to 10 years of Legal & Compliance experience (at least 2/3 in Pharma Company or Pharma Consultancy)
• Prior role as Head of Legal, Compliance Officer, or General Counsel
• Experience in multinational Company
• Strong knowledge of pharmaceutical regulations
• Experience with anti‑corruption frameworks and corporate liability models (e.g., 231)
• Solid understanding of GDPR and data protection requirements
• Excellent contract drafting and negotiation skills.
• Experience managing regulatory inspections and government authority interactions;
• Law degree or higher qualification;
• Fluency in English;

Workplace: Milan