Legal & Compliance Manager
Descrizione dell'offerta
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 withanti-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