REGULATORY AND COMPLIANCE SENIOR MANAGER

REGULATORY AND COMPLIANCE SENIOR MANAGER

Business unit: Market Access; Regolatorio; Supply Chain

Location: Italia/Lombardia/Milano

For an International Pharmaceutical Company, Pharma Point is looking for a Regulatory and Compliance Senior Manager.

The role involves overseeing Regulatory Affairs, Compliance, National Market Access, and Supply Chain Management, ensuring all activities comply with local regulations and corporate policies. The position requires coordination with global teams and health authorities.

Key Responsibilities:

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

Required Skills & Knowledge:

1. In-depth understanding of local health authorities (AIFA, Ministry of Health) and regulations on drug commercialization.
2. Strong project management and communication skills.
3. Fluent in English and able to operate strategically and operationally.

Experience & Qualifications:

1. Degree in Pharmacy.
2. At least 6 years of experience in regulatory and compliance roles within the pharmaceutical industry.