Job title: Junior regulatory associate (navitas)

Roles and Responsibilities

Job Description

• We are looking for a Junior Regulatory Associate to support our Publishing and Submissions team. The applicant must be able to:

  • Understand the requirements for various regulatory submissions including, but not limited to: IND, ANDA, NDA, and DMF in CTD/eCTD formats for a number of regulatory agencies including the US-FDA, EMA, Health Canada, etc.

  • Assist Regulatory Associates/Senior Regulatory Associates in document level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines.

  • Carry out Submission Publishing Support, archiving and/or review of same day dispatch, major/complex submissions

• Ensure compliance with customer SOP's and Policies as well as adhere to the organization's policies and procedures

Desirable Skills and Experience

• Experience in Publishing and Submissions is required.