Regulatory Site Officer

Sanofi

Waterford, Ireland
Onsite
Regulatory dossier maintenance
Regulatory submissions tracking
Quality documentation review
Sanofi Waterford is a state-of-the-art biopharmaceutical and medical device campus with almost 800 employees and offers flexible working and onsite health and wellbeing facilities

Job Summary

  • Sanofi Waterford is a state-of-the-art biopharmaceutical and medical device campus with almost 800 employees and offers flexible working and onsite health and wellbeing facilities.
  • The Regulatory Affairs Department manages products from a regulatory perspective, ensuring timely submissions, assessing changes, and maintaining compliance with Health Authorities.
  • The role involves coordinating regulatory requests, reviewing quality documentation, participating in inspections, and contributing regulatory guidance to project teams.

Matching Summary

Sanofi Waterford is a state-of-the-art biopharmaceutical and medical device campus with almost 800 employees and offers flexible working and onsite health and wellbeing facilities.

Skills & Requirements

Must-have

  • Regulatory dossier maintenance
  • Regulatory submissions tracking
  • Quality documentation review
  • Health Authority interactions
  • Regulatory compliance monitoring

Nice-to-have

  • Problem solving skills
  • Effective communication
  • Critical thinking
  • Time management
  • Team collaboration

Key Requirements

  • Degree in Science, Pharmacy or related discipline
  • 2+ years in a similar regulatory role
  • Experience with Health Authorities
  • Knowledge of Manufacturing and Quality Operations

Work Rights

Not specified

Tailored Resume

Cover Letter