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Manager, Regulatory Clinical Trials

Company

Takeda

Location

Gurgaon, Haryana

Type

Full time

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:

  • Manage and lead preparation, submission, and tracking of CTAs, substantial/non-substantial amendments, notifications, and other required submissions to Indian Health Authorities (CDSCO) as applicable.
  • Ensure timely, complete, and compliant responses to HA questions/deficiency letters to prevent av...

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