Manage timelines for query responses and ensure on-time submission through SUGAM portal or other regulatory platforms
Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders
Strong communications skills and ability to guide and mentor team members
Ability to work in different time zones

2-4 yrs in-depth knowledge of Indian regulatory guidelines for clinical trials, including NDCT Rules
Hands-on experience with SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments
Ability to liaise effectively with global sponsors and cross-functional teams
Strong understanding of global regulatory expectations and harmonization with Indian requirements
Acquired hands-on expertise in managing and completing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal
Updated with current Guidelines and Gazette Notifications to give suggestions/comments to respective Regulatory authorities and Govt. regulatory bodies
Working knowledge of India regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
Clear oral and written communication skills
Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders
Ability to work independently

Regulatory Affairs Associate, Clinical Trial Application

Key skills