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

Junior

Regulatory Affairs

Full Time

📌 Senior Regulatory Associate Chennai (India)
🏢 Navitas Life Sciences
📍 India