Senior Regulatory Affaist Specialist

GSK

Products registration and lifecycle management
Regulatory submission leadership
Regulatory agency guidelines knowledge
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together

Job Summary

  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
  • The role involves planning and managing regulatory affairs strategies for new chemical entities, line extensions, and new indications to meet approval timelines.
  • GSK is committed to creating an inclusive workplace and providing equal opportunities for all applicants while embracing an agile working culture.

Matching Summary

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

Skills & Requirements

Must-have

  • Products registration and lifecycle management
  • Regulatory submission leadership
  • Regulatory agency guidelines knowledge
  • Global and regional communication
  • Registration planning and strategy
  • Regulatory update and maintenance

Nice-to-have

  • Bridging strategy development
  • Stakeholder engagement
  • Impact analysis of guideline amendments
  • Collaboration with global regulatory affairs
  • Agile working culture

Key Requirements

  • Bachelor’s degree in pharmacy
  • Minimum 6+ years regulatory experience
  • Experience in regulatory submissions and review process
  • Proficient English communication

Work Rights

Not specified

Tailored Resume

Cover Letter