Ra (senior) Specialist/associate Manager

AstraZeneca

Seoul, South Korea
5+ years regulatory experience in pharma
Korean and english language proficiency
Knowledge of korean mfds regulations
The role involves developing regulatory strategies for the earliest market entry of new pharmaceutical products in Korea

Job Summary

  • The role involves developing regulatory strategies for the earliest market entry of new pharmaceutical products in Korea.
  • Candidates must maintain high-level satisfaction with local authorities while ensuring compliance with Korean and AstraZeneca procedures.
  • This position requires gathering intelligence on regulatory changes and managing relationships with government agencies and contractors.

Matching Summary

The role involves developing regulatory strategies for the earliest market entry of new pharmaceutical products in Korea.

Skills & Requirements

Must-have

  • 5+ years regulatory experience in pharma
  • Korean and English language proficiency
  • Knowledge of Korean MFDS regulations
  • Product registration strategy development
  • Good Regulatory Practice (GRP) compliance

Nice-to-have

  • Experience with cross-functional teams
  • Drug development process knowledge
  • Strong relationship building with authorities
  • Ability to harmonize product labels globally

Key Requirements

  • BA or MA in biology-related science (pharmacy preferred)
  • Minimum 5 years of regulatory experience
  • 5-10 years of pharma industry experience
  • No foreign travel disqualification issues

Work Rights

Must not have foreign travel disqualification; citizenship status not explicitly defined but local presence implied

Tailored Resume

Cover Letter