Senior Regulatory Affaist Specialist

gssi.world

Bachelor's degree in pharmacy
6+ years regulatory experience
Leadership of regulatory submissions
The role focuses on the registration and life cycle management of products including labeling updates and license maintenance

Job Summary

  • The role focuses on the registration and life cycle management of products including labeling updates and license maintenance.
  • Candidates will establish short- and long-term detailed registration plans to meet expected approval timelines for new compounds and line extensions.
  • GSK is committed to uniting science, technology, and talent to positively impact the health of 2.5 billion people by the end of the decade.

Matching Summary

The role focuses on the registration and life cycle management of products including labeling updates and license maintenance.

Skills & Requirements

Must-have

  • Bachelor's degree in pharmacy
  • 6+ years regulatory experience
  • Leadership of regulatory submissions
  • Knowledge of agency guidelines
  • Proficient English communication

Nice-to-have

  • Experience with NCE and LE registration
  • Strategic planning for new indications
  • Relationship management with authorities
  • Agile working culture adaptability

Key Requirements

  • Bachelor's degree in pharmacy required
  • Minimum 6+ years in regulatory affairs
  • Proven leadership in delivering regulatory submissions
  • Deep knowledge of regulatory agency guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter