Sr. Regulatory Affairs Specialist (18 Months Contract)

Viatris

Korea
Hybrid
Mfds marketing approval
New drug filings
Post-approval changes
Viatris is seeking a Senior Regulatory Affairs Specialist for an 18-month contract in Korea. The role involves preparing regulatory submissions, maintaining product approvals, and collaborating across functions to ensure compliance with local regulations

Job Summary

  • Prepare filing & obtain marketing approval from the MFDS for the new drug and planned variations to ensure maintenance of registered drugs.
  • Provide regulatory insight & strategies to cross function team as regulatory liaison throughout the product lifecycle.
  • Viatris empowers people worldwide to live healthier at every stage of life through access, leadership, and partnership.

Matching Summary

Match Score: 85

Viatris is seeking a Senior Regulatory Affairs Specialist for an 18-month contract in Korea. The role involves preparing regulatory submissions, maintaining product approvals, and collaborating across functions to ensure compliance with local regulations.

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
  • stability in evolving healthcare
  • collaboration with stakeholders
  • decision making
  • negotiation skill

Key Requirements

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

Work Rights

Not specified

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