Regulatory Submissions Coordinator (Senior/ Experienced)
Core
Senior coordinator managing regulatory submissions and site activation for clinical trials in India.
Role type
Senior Clinical Operations Regulatory Submissions Coordinator
Builds
Regulatory documentation and site activation packages for clinical trials
Domain
Clinical Research / Regulatory Affairs
Required skills
Regulatory submission preparation, site activation management, risk mitigation, compliance with local regulations, document review, query response formulation
Preferred skills
CRO experience, regional APAC experience, travel to Delhi
Technologies
CDSCO, DCGI, EC, RA
Responsibilities
Prepare, review, and submit regulatory documentation to Ethics Committees and Regulatory Authorities; coordinate site activation activities; communicate with global study teams; identify and mitigate risks to site activation; advise sponsors on changing regulations; track submission timelines
Seniority
Senior, hands-on IC
