Senior Executive / Assistant Manager RAD

8 - 10 years

6 - 10 Lacs

Posted:2 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  1. New submissions - DMF compilation and submission to global health agencies.
  2. Life cycle management Amendments and Revisions - Compilation and submission to global health agencies.
  3. Deficiency handling – Coordinating with CFT and to get required data for review, compilation and submission.
  4. eCTD – Handson experience on eCTD tools for new submissions/revisions/response submission.
  5. Post approval – Communication with customers for proposed changes.
  6. Maintaining and managing various dashboards/back up raw data.

Skills required:

  1. Good understating of ICH guidance
  2. Clarity on regulatory guidance documents on post approval changes
  3. Experience in compilation/review of all the modules for API submission and life cycle management.

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