Technical Regulatory Associate

Technical Regulatory Associate – 12 month temporary position in the Quality Systems – Technical Regulatory & Change Control area at the Borgo San Michele production site, Latina, Italy.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Business Enablement/Support

Location

Latina, Italy

Scope

The role supports the Department of Quality Systems by ensuring product compliance with national and international regulations, focusing on GMP and SOP adherence. The incumbent collaborates with CMC, Regulatory Affairs, and external regulatory bodies to prepare and manage registration documentation, conduct compliance checks, and maintain regulatory master data.

Responsibilities

• Prepare international registration documentation in collaboration with the CMC Regulatory Affairs team and external customers, maintaining contact with regulatory bodies to streamline information exchange.
• Prepare local registration documentation in partnership with Regulatory Affairs at Janssen‑Cilag, Milano.
• Collect and process all information and certifications required from affiliates for their respective authorities, alongside registration documentation.
• Compile regulatory master data (e.g., SAP) for new product and material codes and changes, ensuring proper implementation of shelf‑life and related procedures.
• Execute regulatory compliance checks on clinical production lots according to management procedures.
• Ensure proper archiving of registration documents in line with management procedures, guaranteeing availability and readiness for inspections.

Qualifications

• Master’s degree in Chemical and Pharmaceutical Technologies, Pharmacy, Chemistry, or Biology.
• 12 months of experience in the pharmaceutical sector or similar.
• Excellent knowledge of English.
• Good command of the Office suite.