Jobs in Milano, Italia

Client: Pharma Point Srl

Location: Milan

Job Category: Other

EU work permit required: Yes

Job Reference: 921a2f6223c4

Job Views: 2

Posted: 24.04.2025

Expiry Date: 08.06.2025

Pharma Point is seeking a Regulatory and Compliance Senior Manager for an international pharmaceutical company. The role involves overseeing Regulatory Affairs, Compliance, National Market Access, and Supply Chain Management, ensuring adherence to local regulations and corporate policies. The position requires coordination with global teams and health authorities.

1. Regulatory Affairs: Manage regulatory procedures, including marketing authorization, artwork approval, and local regulatory intelligence. Collaborate with local health authorities (AIFA), global teams, and external consultants.
2. Compliance: Ensure compliance with pharmaceutical regulations, develop compliance processes, train staff, and conduct risk assessments. Collaborate with the global legal team and oversee tax-related topics.
3. Data Protection: Act as the primary contact for Data Protection Officer, ensuring coordination on data privacy issues.
4. Market Access & Supply Chain: Manage national and regional market access, coordinate stock situations with distributors, and communicate effectively during out-of-stock situations.
5. Quality & Inspections: Work with the Quality Manager to ensure inspection readiness and CAPA execution.

• Deep understanding of local health authorities (AIFA, Ministry of Health) and drug commercialization regulations.
• Strong project management and communication skills.
• Fluency in English; strategic and operational capabilities.

• Degree in Pharmacy.
• Minimum 6 years of experience in regulatory and compliance roles within the pharmaceutical industry.