Regulatory Start-Up Specialist

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.

• Education : Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, or related field.
• Experience : 1-3 years in clinical research, regulatory affairs, or site activation.
• Knowledge : Familiarity with ICH-GCP standards and local regulatory requirements.
• Skills : Strong organizational, communication, and problem-solving abilities; proficiency with databases and tracking tools.