Managing the regulatory sciences function at Sri Research.
The responsibilities include
a) Regulatory activities related to obtaining approvals for Phase 1 & 2 clinical trials for new tissue engineering technologies
b) Preparing clinical trials applications and follow-up on submissions to relevant ISB/Ethics Committees, DCGI/ICMR and other statutory authorities
c) Ensuring compliance with all regulatory standards for SRTE's research and development programs.
The candidate should be a Graduate/Post-Graduate in Phamaceutical sciences/Biotechnology or having a MBBS degree from any repurted institution with 7-10 years experience in organizing clinical trials, liasoning with regulatory agencies such as the DCGI, ICMR and state level organizations for clincal research. The role would involve siginficant interactions with SRTE's scientific team, management as well as external agencies like the DCGI/ICMR and other state Government agencies. The person should have very good communication and inter-personal skills in addition to good functional expertise in the clinical trials domain. Position is based at Bangalore, India and reports to the Head of the organization.