Description

OBJECTIVES/PURPOSE: Manager, Clinical Regulatory Affairs (India) is responsible for managing regulatory activities for clinical trials in India and managing/ supporting preparation, submission, Q&A and maintenance of Clinical Trial Applications (CTAs), amendments, and responses to Health Authority (HA) queries at LOC level, and supports HA interactions including Subject Expert Committee (SEC) preparation. This position works in close alignment with the Global/International Regulatory Clinical Trials team, GDO, India R&D, Medial team and external partners (e.g., CROs) for Clinical trials in India.

KEY JOBS ACCOUNTABILITIES: