Sr. Regulatory Affairs Specialist (18 Months Contract)

Viatris Korea

Korea, Republic of
Not specified (assumed to be in-office based on the nature of the role).
Mfds marketing approval
New drug filings
Post-approval changes
Viatris Korea is seeking a Sr. Regulatory Affairs Specialist for an 18-month contract position focused on obtaining marketing approvals and managing regulatory compliance for new and existing pharmaceutical products. The ideal candidate will have a background in regulatory affairs within the pharmaceutical industry, particularly in post-approval changes, and possess strong communication and project management skills

Job Summary

  • Sr. Regulatory Affair Specialist is responsible for preparing regulatory submission materials for new drugs and planned variations, and coordinating with the MFDS.
  • The role involves maintaining registered drugs, providing regulatory insights and strategies, and managing country labeling documents and related updates.
  • Viatris offers competitive salaries, benefits, and an inclusive environment where you can make an impact on the lives of others.

Matching Summary

Match Score: 85

Viatris Korea is seeking a Sr. Regulatory Affairs Specialist for an 18-month contract position focused on obtaining marketing approvals and managing regulatory compliance for new and existing pharmaceutical products. The ideal candidate will have a background in regulatory affairs within the pharmaceutical industry, particularly in post-approval changes, and possess strong communication and project management skills.

Skills & Requirements

Must-have

  • MFDS marketing approval
  • new drug filings
  • post-approval changes
  • labeling document maintenance
  • regulatory liaison
  • external regulatory environment awareness

Nice-to-have

  • strategic thinking
  • courageous action
  • collaboration
  • innovative solutions
  • agile to change

Key Requirements

  • Bachelor degree in Pharmacy
  • 4-5 year experience in Regulatory affairs
  • RA experience managing post approval change
  • Fluency in English and Korean

Work Rights

Not specified

Tailored Resume

Cover Letter