Senior Regulatory Affaist Specialist

GSK

Bachelor's degree in pharmacy
6+ years regulatory experience
Knowledge of regulatory agency guidelines
The role involves planning the best-case scenarios for RA plans for Line Extensions and New indications while sharing strategies with stakeholders

Job Summary

  • The role involves planning the best-case scenarios for RA plans for Line Extensions and New indications while sharing strategies with stakeholders.
  • Candidates must maintain good relationships with regulatory authorities and internal stakeholders to ensure timely approval timelines.
  • GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease together.

Matching Summary

The role involves planning the best-case scenarios for RA plans for Line Extensions and New indications while sharing strategies with stakeholders.

Skills & Requirements

Must-have

  • Bachelor's degree in pharmacy
  • 6+ years regulatory experience
  • Knowledge of regulatory agency guidelines
  • Experience with submission review process
  • Proficient English communication skills

Nice-to-have

  • Leadership and delivery of submissions
  • Strategic planning for NPI or Launch Excellence
  • Ability to manage third-party support
  • Collaboration with global colleagues

Key Requirements

  • Bachelor's degree in pharmacy required
  • Minimum 6 years of regulatory experience
  • Proven leadership in delivering regulatory submissions

Work Rights

Not specified

Tailored Resume

Cover Letter