Technical Regulatory Associate, Quality Systems

Johnson & Johnson Co.; Latina; On-site; EUR 30,000 - 49,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Job summary

Johnson & Johnson is hiring for a Technical Regulatory Associate at the Latina site, within the Quality Systems department. You will manage change requests from QA, coordinate cross-functional teams, and ensure regulatory documentation complies with GMP and international standards.

The role requires a Master’s degree in a pharmaceutical-related field and 1–3 years of QA experience. The position offers growth within a global healthcare leader, with emphasis on regulatory submissions, lifecycle

Qualifications

• Master's degree in a relevant scientific field
• 1–3 years experience in Quality Assurance
• Good knowledge of GMP and regulatory requirements

Responsibilities

• Manage Change Requests (local and international) from QA perspective (evaluate, coordinate, approve, close)
• Check completeness and accuracy of activity plans for change requests and ensure timely execution
• Engage international functions when needed for change requests
• Evaluate and approve Change Requests from QA perspective during CC Committee review
• Serve as site liaison for Latina for change requests initiated by external sites
• Prepare international registration documentation with CMC Regulatory Affairs and external stakeholders
• Prepare local registration documentation with Regulatory Affairs (Janssen-Cilag, Milan)
• Gather and process information and certifications from affiliates for regulatory bodies
• Populate master data (e.g., SAP) for regulatory codes and shelf-life implementation
• Perform regulatory compliance checks on clinical batch materials as per SOPs
• Store and archive regulatory documents to ensure readiness for inspections

Skills

GMP knowledge

Change Control

Quality documentation

Quality systems

Regulatory awareness

Education

Master's degree in Chemical and Pharmaceutical Technologies, Pharmacy, Chemistry or Biology

Tools

SAP

Job description

Johnson & Johnson is hiring for a Technical Regulatory Associate at the Latina site, within the Quality Systems department. You will manage change requests from QA, coordinate cross-functional teams, and ensure regulatory documentation complies with GMP and international standards.

The role requires a Master’s degree in a pharmaceutical-related field and 1–3 years of QA experience. The position offers growth within a global healthcare leader, with emphasis on regulatory submissions, lifecycle