Quality Regulatory Compliance Specialist – Maternity Replacement

Gsicareers

Siena, Italy
Hybrid
Regulatory submissions and communications
Regulatory compliance and data accuracy
Liaison between departments
The role ensures regulatory submissions and communications accurately reflect site operations, ensuring regulatory compliance and data accuracy

Job Summary

  • The role ensures regulatory submissions and communications accurately reflect site operations, ensuring regulatory compliance and data accuracy.
  • Key responsibilities include coordinating regulatory submissions, performing preliminary regulatory assessments of Change Requests, and managing responses to Health Authorities.
  • GSK offers a competitive salary, annual bonus, healthcare and wellbeing programs, pension plan, and a hybrid working model through its Performance with Choice program.

Matching Summary

The role ensures regulatory submissions and communications accurately reflect site operations, ensuring regulatory compliance and data accuracy.

Skills & Requirements

Must-have

  • Regulatory submissions and communications
  • Regulatory compliance and data accuracy
  • Liaison between departments
  • Regulatory assessment of Change Requests
  • Source document verification and management
  • Subject Matter Expert engagement
  • Response management for Health Authorities

Nice-to-have

  • Continuous improvement mindset
  • Team collaboration and conflict resolution
  • Innovative idea generation
  • Proactive risk mitigation

Key Requirements

  • Degree in scientific fields
  • Experience in pharmaceutical company
  • Excellent English proficiency
  • Proficiency in IT software and digital tools

Work Rights

Not specified

Tailored Resume

Cover Letter