Jain Suvarna

Senior Manager Regulatory Affairs @Sandoz

Mumbai, IN

Leading a team.Blend of Regulatory expert. Worked for all scope ( US/EU/ROW) new submission and also effectively maintaining product lifecycle for all scope ( US/EU/CA/ROW)Directs the development of submission of product registration, progress reports, supplements, amendments, and variation application. Contributes to and often leads the global project for process improvement.• People Management responsibility including development and coaching of direct reports.• Ensure collaborative working relationship with internal cross functional stakeholders• Leadership initiatives, Simplification of procedures, coaching of direct reports, Ensure Timely responses to HA queries, Keep regulatory knowledge upto date for newer regulatory guidelines and impact assessment• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.• Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.• Serves as a regulatory liaison on the project team throughout the product lifecycle.• Provides regulatory advice to commercial teams on manufacturing changes, line extensions, Regulatory application, appropriate regulations and interpretations.• Review various Regulatory submission application.• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.• Provides input into global regulatory strategy and contributes in identification of gaps or risks in global strategic plan for assigned regions.• Provides regulatory strategy in order to fulfil business objectives• Develops team and implements plans for timely response to HA requests and coordinates responses.• Drives coordination, planning, and submission of dossiers/variation application in assigned regions worldwide.