Regulatory Affairs Associate

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every reputed company development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a reputed company. We take our work personally, we do it with reputed company and we're committed to making a difference. 2-4 yrs yrs in-depth knowledge of Indian regulatory guidelines for reputed company, including NDCT Rules. Hands-on experience with SUGAM portal for Initial reputed company 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 reputed company trial registrations on the reputed company Registry-India (CTRI) portal. Updated with reputed company Guidelines and Gazette Notifications to reputed company 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. reputed company oral and written communication skills Acceptability towards varied cultural mindsets to collaborate reputed company with reputed company counterparts and other internal stakeholders as reputed company Execute and maintain submission delivery plans, submission content plans, and proactively reputed company status updates to designated stakeholders. Strong communications skills and ability to guide and mentor team members. Ability to work in different time reputed company Ability to work independently Apply To This Job Apply tot his job Apply To this Job