Sr. Regulatory Affairs Specialist (18 Months Contract)

Viatris Korea

Hybrid
Mfds marketing approval
New drug filing
Product lifecycle management
Viatris Korea is seeking a Sr. Regulatory Affairs Specialist for an 18-month contract. The role involves preparing regulatory submissions, maintaining product registrations, and collaborating with internal teams and regulatory authorities to ensure compliance

Job Summary

  • Prepare filing & obtain marketing approval from the MFDS for the new drug and planned variations to ensure maintenance of registered drugs.
  • Maintain country labeling documents & related works (such as labeling, artwork review/approval, relevant internal system and database updates).
  • Establishes, develops and maintains close working relationships with the relevant regulatory authorities and associations.

Matching Summary

Match Score: 85

Viatris Korea is seeking a Sr. Regulatory Affairs Specialist for an 18-month contract. The role involves preparing regulatory submissions, maintaining product registrations, and collaborating with internal teams and regulatory authorities to ensure compliance.

Skills & Requirements

Must-have

  • MFDS marketing approval
  • new drug filing
  • product lifecycle management
  • labeling document maintenance
  • regulatory liaison

Nice-to-have

  • strategic thinking
  • cross-functional collaboration
  • competitive intelligence
  • agile to change
  • decision making

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter