Executive / Officer - RA - EU Market

Job highlights

• Experience in EU and UK regulatory markets with expertise in authoring modules 1-5 and handling post approval variations

• Support authoring and compiling regulatory documents, respond to health agency queries, and ensure compliance with eCTD and ICH guidelines

• Must have Regulatory Market experience like EU and UK countries.

• Must have worked and support authoring module 1-5.

• Should have good experience of post approval variation &
  Initial marketing authorizing application experience is add on.

• Should have worked on health agency query, awareness of docs like eCTD, ICH guidelines.

• Should have worked in compilation and reviewing the documents.