Regulatory Affairs Associate

Parexel • Full-time • Remote (India) • 4h ago

2-4 yrs 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.
Prepare necessary documentation, presentations, and briefing materials for SEC meetings
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
Manage timelines for query responses and ensure on-time submission through SUGAM portal or other regulatory platforms.
Clear oral and written communication skills
Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
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
Ability to work independently

#LI-REMOTE

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