Legal & Compliance Manager

About the role

Celltrion Healthcare Italy, part of the Celltrion Group, which supplies biosimilar and innovative biopharmaceutical products to about 110 countries, is looking for a highly motivated Legal & Compliance Manager with a strong legal background and proven experience in a similar role. The company is fast-growing and has a diversified product pipeline across several therapeutic areas. The workplace is in Milan.

Key responsibilities

• Ensure full compliance with data protection laws and oversee data governance (GDPR)
• Implement and monitor the organizational model under Legislative Decree 231/2001
• Conduct periodic compliance risk assessments and define mitigation plans
• Support and coordinate the activities of the Supervisory Body (OdV)
• Ensure transparency reporting and disclosure of transfers of value (Sunshine Act)
• Lead internal compliance audits and manage corrective action plans
• Develop, update and monitor standard operating procedures, and design internal controls and governance frameworks
• Draft, review and negotiate corporate agreements, and provide day-to-day legal advice to internal departments
• Oversee debt collection and handle pre-litigation matters, coordinating external counsel in litigation
• Support regulatory, quality, AIFA relations and CRO activities

Required profile

• At least 5 years of experience in senior Legal & Compliance roles, preferably in pharma or healthcare
• Prior role as Head of Legal, Compliance Officer or General Counsel
• Experience in a multinational company
• Law degree or higher qualification
• Fluency in English
• Proactive, pragmatic, flexible, solution-oriented, with strong interpersonal and leadership skills

Required skills

• Pharmaceutical regulations and corporate governance
• Anti-corruption frameworks and corporate liability models such as 231
• Solid understanding of GDPR and data protection
• Excellent contract drafting and negotiation skills
• Managing regulatory inspections and government authority interactions