Quality Regulatory Compliance Specialist – Maternity Replacement

GSK

Siena, Italy
Hybrid
Regulatory submissions and health authority communications
Regulatory compliance and data accuracy
Coordination between regulatory affairs, operations, and quality
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 the preparation, review, and approval of regulatory submission packages and performing preliminary regulatory assessments of Change Requests.
  • The company offers a competitive salary, annual bonus, healthcare and wellbeing programs, pension plan, and a hybrid working model.

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 health authority communications
  • Regulatory compliance and data accuracy
  • Coordination between Regulatory Affairs, Operations, and Quality
  • Review and approval of regulatory submission packages
  • Regulatory assessment of Change Requests
  • Management of responses to Health Authorities

Nice-to-have

  • Continuous improvement mindset
  • Collaborative team environment
  • Innovation for quality and sustainability

Key Requirements

  • Degree in scientific subjects
  • Experience in pharmaceutical company
  • Excellent English language skills
  • Proficiency in IT software and digital tools

Work Rights

Not specified

Tailored Resume

Cover Letter