Regulatory Affairs Specialist

GlaxoSmithKline

Riyadh, Saudi Arabia
Sfda submissions and lifecycle management
Regulatory labelling and packaging
Cross-functional regulatory activities
Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies

Job Summary

  • Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies.
  • Coordinate and review regulatory labelling and packaging (including Arabic translations) to ensure SFDA compliance.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

Matching Summary

Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies.

Skills & Requirements

Must-have

  • SFDA submissions and lifecycle management
  • regulatory labelling and packaging
  • cross-functional regulatory activities
  • liaise with global and local stakeholders
  • maintain regulatory tracking dashboards
  • communicate with SFDA via approved channels

Nice-to-have

  • price negotiation or pricing appeals
  • liaising with scientific office
  • providing pharmacovigilance oversight

Key Requirements

  • Bachelor’s degree in pharmacy, Pharmaceutical Sciences or related life sciences field
  • 1–3 years’ Regulatory Affairs experience
  • Fluent in Arabic and English (written and spoken)
  • Mandatory Saudi national
  • Saudi-licensed pharmacist

Work Rights

Mandatory Saudi national

Tailored Resume

Cover Letter