Senior Regulatory Affaist Specialist

GSK

Seoul, South Korea
Product registration and lifecycle management
Regulatory submissions
Regulatory agency guidelines
Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up

Job Summary

  • Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up.
  • Planning the best-case scenarios of RA plans for Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Mtg.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

Matching Summary

Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up.

Skills & Requirements

Must-have

  • product registration and lifecycle management
  • regulatory submissions
  • regulatory agency guidelines
  • regulatory agency review process
  • English communication proficiency

Nice-to-have

  • uniting science, technology and talent
  • getting ahead of disease together
  • inclusive workplace and equal opportunities
  • agile working culture

Key Requirements

  • Bachelor’s degree in pharmacy
  • Minimum 6+ years of experience in regulatory
  • leadership and delivery of a range of regulatory submissions
  • Proficient English communication

Work Rights

Not specified

Tailored Resume

Cover Letter