Job Title : Regulatory Start-Up Specialist

Job Location : Mumbai / Bangalore

Essential Functions :

• Serving as the Single Point of Contact (SPOC) for investigative sites, Site Activation Managers (SAMs), and Project Management teams.
• Performing start-up and site activation activities in compliance with regulations, SOPs, and work instructions.
• Preparing and reviewing site regulatory documents for completeness and accuracy.
• Maintaining internal systems, databases, and tracking tools with project-specific information.
• Reviewing and providing feedback on site performance metrics.
• Establishing and agreeing on project planning and timelines , and implementing contingency plans as needed.
• Informing team members about the completion of regulatory and contractual documents.
• Tracking and following up on the progress of various documents and approvals.
• Providing local expertise to SAMs and project teams during project timeline planning.
• Performing quality control of documents provided by sites.
• Potentially having direct contact with sponsors on specific initiatives.

Qualifications :