Regulatory Associate - Trainee

Job Description

We are looking for a Regulatory Associate. The successful candidate will:

  • Understand the requirements of various regulatory submissions including: IND, ANDA, NDA and DMF in CTD/eCTD formats for various regulatory agencies including: US-FDA, EMA, Health Canada, etc.
  • Assist Regulatory Associates/Senior Regulatory Associates with document level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines.
  • Provide Submission Publishing Support, archiving and/or review of same day dispatch, major/complex submissions
  • Be compliant with customer SOP's and Policies as well as adhering to the organization's policies and procedures

Desirable Skills and Experience

  • Experience in Publishing and Submissions is required

Chennai, India

Bachelor’s Degree in Pharma


Clinical Research

Full Time

18 Feb 2021