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Senior Regulatory Affairs Consultant

  • Location:

    Seoul, Republic of Korea

  • Contact:

    Michael Rownicki

  • Job type:

    Contract

  • Contact phone:

    +353 21 485 7227

  • Industry:

    Biotechnology

  • Contact email:

    michael_rownicki@oxfordcorp.com

OXFORD OPPORTUNITY
Senior Regulatory Affairs Consultant

Client industry:PharmaSchedule:5 Days per week
Position:Senior RALocation:Seoul, Korea
Start date:ASAPLOA:6 months, 6 month extension
On site/remote:HybridLanguages:English


PROJECT DESCRIPTION
Our client who are preparing for an Inspection from Authorities are looking for a consultant who can complete a new full eCTD product registration dossier in English written to global standards (US+JP+CN+EU) written for an originator and / or a branded generic pharmaceutical product.
The position will require 40hrs per week with time spent in the Head Office in Seoul and the manufacturing site further outside of the city.
Start date is as soon as possible

CONSULTANT RESPONSIBILITIES

  • Previous experience of Chinese, Japanese, EU and US Authorities
  • eCTD product registration-Global Standards
  • Creation of eCTD from start to finish