ITALY - Legal & Compliance Manager
Core
Manage legal and compliance operations for a biosimilar and biopharmaceutical company in Italy, ensuring adherence to pharmaceutical regulations, data protection laws, and anti-corruption frameworks.
Role type
Senior Legal & Compliance Manager
Builds
Compliance frameworks, internal controls, and legal governance for a global biopharmaceutical organization
Domain
Biopharmaceuticals / Healthcare
Deliverable
client delivery
Required skills
Pharmaceutical regulations, anti-corruption frameworks, GDPR/data protection, contract drafting and negotiation, risk assessment, internal audit, regulatory inspection management
Preferred skills
Organizational Model (Legislative Decree 231/01) implementation, Sunshine Act reporting, dispute management, regulatory authority relations
Technologies
None stated
Responsibilities
Ensure compliance with data protection laws (GDPR); Implement and monitor Organizational Model pursuant to Legislative Decree 231/2001; Conduct periodic compliance risk assessments; Support and coordinate activities of the Supervisory Body; Ensure transparency reporting under Sunshine Act; Lead internal compliance audits; Develop and monitor Standard Operating Procedures; Design and strengthen internal controls; Draft, review, and negotiate corporate agreements; Provide day-to-day legal advice; Oversee debt collection and recovery actions; Handle pre-litigation matters and coordinate external counsel; Support Regulatory, Quality, AIFA Relations, and CRO activities
Seniority
Senior, hands-on IC