Senior Regulatory Affairs Associate
Primary Location: India, Remote 求人ID R0000036892 Category Regulatory / ConsultingAbout this Role
- 4-7 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
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