Technical Regulatory Associate

Johnson & Johnson

Latina, Italy
Quality systems
Technical regulatory & change control
Gmp compliance
The role is responsible for ensuring product quality compliance with national and international pharmaceutical regulations, both in terms of product control and related documentation

Job Summary

  • The role is responsible for ensuring product quality compliance with national and international pharmaceutical regulations, both in terms of product control and related documentation.
  • Key responsibilities include preparing international and local registration documentation, collecting and processing information for affiliates, and compiling regulatory master data.
  • The position requires ensuring correct archiving of registration documents for availability and inspection readiness.

Matching Summary

The role is responsible for ensuring product quality compliance with national and international pharmaceutical regulations, both in terms of product control and related documentation.

Skills & Requirements

Must-have

  • Quality Systems
  • Technical Regulatory & Change Control
  • GMP compliance
  • International registration documentation
  • Local registration documentation
  • SAP master data compilation

Nice-to-have

  • Accountability
  • Analytical Reasoning
  • Communication skills
  • Process Oriented
  • Data Savvy

Key Requirements

  • Master's degree in Chemistry and Pharmaceutical Technology, Pharmacy, Chemistry, or Biology
  • 12 months experience in the pharmaceutical sector
  • Excellent knowledge of English
  • Good knowledge of the Office package

Work Rights

Not specified

Tailored Resume

Cover Letter