Regulatory Affairs Associate

Parexel • Bengaluru, Karnataka • Posted July 19, 2026

Position Overview

When our values align, there's no limit to what we can achieve.
 

Job Summary:

The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

Key Responsibilities:

  • Lead end-to-end CTA project management across multiple studies and countries

  • Plan, track, and deliver submissions aligned with timelines and regulatory requirements

  • Manage risks, dependencies, and complexities in global regulatory environments

  • Apply knowledge of EU CTR and ROW CTA requirements

  • Manage core clinical and regulatory documentation

  • Collaborate with cross-functional global teams