Senior Regulatory Associate

Job Description

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

  • Be responsible for publishing, dispatching, and archiving Regulatory Submissions in agency recommended formats
  • Be responsible for supporting regulatory audits and related compliance activities
  • Ensure the timely delivery of high-quality Regulatory Submissions following client and internal processes.
  • Prepare submission ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents
  • Develop and maintain up-to-date knowledge of established agency standards and procedures for Regulatory Submissions.
  • Troubleshoot document issues with Adobe Acrobat and MS Word
  • Manage technical aspects for assigned submissions and status updates
  • Collaborate with various departments for the planning, preparation, publishing, and quality control checks of submissions.
  • Have prior experience and knowledge of various Publishing and Validation tools
  • Train and mentor junior staff members.
  • Assist in revisions of department SOPs, Work Instructions, and training materials

Desirable Skills and Experience

  • Experience in Publishing and Submissions is required

Chennai, India

Bachelor’s Degree in Pharma


Regulatory Affairs

Full Time

18 Feb 2021