Legal & Compliance Manager (Pharma Sector)

Celltrion Healthcare Italia; Bardi; In loco; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

Celltrion Healthcare Italia cerca un Senior Legal & Compliance Manager con 5+ anni di esperienza in ruoli simili, preferibilmente nel pharma. Sarà responsabile di GDPR, modello 231/01 e governance, oltre a risk management e relazione con le autorità.

Il candidato ideale possiede laurea in giurisprudenza, inglese fluente, eccellenti capacità di redazione contratti e leadership. Lavoro in Milano, in contesto internazionale con sfide di conformità e integrità.

Competenze

• Conoscenza consolidata di normative farmaceutiche e regole corporate.
• Esperienza in ruoli senior di Legal & Compliance, preferibilmente in pharma.
• Capacità di guidare progetti di conformità e governance.

Mansioni

• Privacy/GDPR: garantire conformità data protection e governance.
• 231/01: implementare modello organizzativo ex Dlgs 231/2001.
• Valutazione rischi: analisi periodiche e piani di mitigazione.
• OdV: supportare e coordinare l'Organismo di Vigilanza.
• Sunshine Act: trasparenza e segnalazione trasferimenti di valore.
• Audit: condurre audit di conformità e azioni correttive.
• SOP: sviluppare e monitorare procedure operative.
• Processi interni: rafforzare controlli e governance.
• Drafting/revisione contratti: negoziare accordi societari.
• Supporto legale: consulenza quotidiana ai reparti interni.
• Debito/recupero: monitoraggio azioni di recupero.
• Contenziosi: gestione pre-giudiziale e coordinamento con avvocati esterni.
• Supporto/regulatory: relazione con autorità regolatorie, CRO, QA.

Conoscenze

Negoziazione contratti

Gestione rischi di compliance

Conoscenza GDPR

Leadership

Inglese fluente

Ispezioni regolatorie

Formazione

Laurea in Giurisprudenza

Descrizione del lavoro

Descrizione dell’offerta di lavoro

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

Range Retributivo: RAL 50.000 € - 90.000 €