ITALY - Legal & Compliance Manager

CelltrionHealthcare; Milano; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

CelltrionHealthcare Italy is seeking a seasoned Legal & Compliance Manager in Milan to lead regulatory affairs, privacy, and governance across its growing pharmaceutical operations. The role requires strong legal expertise, leadership, and a proactive, solution-oriented mindset.

The candidate will oversee data protection, risk assessments, contract drafting, and interactions with authorities, ensuring compliance and ethical standards across the organization.

Competenze

• 5–10 years of Legal & Compliance experience, preferably 2/3 in Pharma.
• 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 (231).
• Solid understanding of GDPR and data protection requirements.
• Excellent contract drafting and negotiation skills.
• Experience managing regulatory inspections and government authority interactions.
• Fluency in English.

Mansioni

• Privacy / GDPR: Ensure full compliance with data protection laws and oversee data governance practices.
• Risk Assessment: Conduct periodic compliance risk assessments and define mitigation 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.

Conoscenze

Regulatory compliance

GDPR

Contract drafting

Risk management

Leadership

Formazione

Law degree

Descrizione del lavoro

## ITALY - Legal & Compliance ManagerPostulerlocations: Milantime type: Full timeposted on: Offre publiée il y a 30 jours ou plusjob requisition id: JR-00000428Celltrion Group fournit des médicaments biosimilaires et biopharmaceutiques innovants afin d'améliorer l'accès des patients aux thérapies avancées dans le monde entier.Celltrion Group distribue ses produits biologiques à environ 110 pays, ainsi qu'à plus de 30 partenaires internationaux dans le monde entier. Grâce à son expérience et aux connaissances accumulées au fil des années sur les marchés pharmaceutiques de pointe dans le monde entier, Celltrion Group sécurise les canaux de distribution et fournit aux patients des biosimilaires à des prix abordables.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