Kartik Bhagat

Regulatory Affairs, Document Publishing Process Lead @Tata Consultancy Services

Nagpur, IN

Regulatory Affairs Experience- Veeva Vault management and optimization- GRO Coordination and mail handlings - Document management and publishing in Viva Vault- Document review, publishing, and life cycle management- Query responses and regulatory support for pre and post-approval data- Excellent communications with stakeholders and regulatory teams- Prepared and submitted required data and reports to regulatory bodies and agencies, ensuring compliance and timely delivery- Collaborated with cross-functional teams, including Planning and Submission staff, to ensure aligned and effective regulatory strategies- Developed and compiled safety, clinical, and quality documents for major submissions, including- Clinical trial applications and reports - Safety reports and adverse event reports - Quality system and compliance documents - Regulatory submissions and document publishingDemonstrated expertise in- Regulatory compliance and reporting- Document management and publishing/ submission- Cross-functional collaboration and communication- Quality and safety managementAchieving regulatory success and driving business growth through- Time management - Quality and compliant regulatory publishing\'s- Effective communication with regulatory agencies/stakeholders - Strategic regulatory publishing planning and implementation

National Junior College

Jr. College

Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

Masters in Pharmacy

MIT School of Distance Education

PGDM

Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

M. Pharmacy

Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

B. Pharmacy