Sajeev

Global Regulatory Submission Specialist

Bristol Myers Squibb

Hyderabad, India

11.2023 - Current

Led global regulatory submission activities across FDA, EMA, and Rest of World (ROW) markets, collaborating cross-functionally to ensure timely, accurate, and compliant dossier delivery, including IND, NDA, BLA, and Orphan Drug submissions.
Served as the primary point of contact between functional contributors and external publishing vendors, ensuring seamless delivery of regulatory submissions and structured archival in Veeva Vault RIM.
Oversaw the end-to-end management of regulatory documents like clinical, non-clinical, safety, and CMC, ensuring collection, tracking, review, and finalization aligned with Health Authority expectations and internal quality standards.
Directed the development and submission of high-priority regulatory documents including CSRs, IBs, SAPs, PADERs, DSURs, Annual Reports, and clinical/non-clinical summaries, integrating inputs from clinical, safety, and medical writing teams.
Managed regulatory system tools and platforms such as Veeva Vault, CARA Prism, DXC Viewer, and eSUB Manager, ensuring controlled workflows, version integrity, and audit-ready documentation.
Led process improvements and operational optimization initiatives, including the development and enforcement of procedures for publishing and document handling, contributing to higher efficiency and compliance.
Actively participated in information system upgrades and system lifecycle projects, ensuring new functionalities and tools align with regulatory business needs and global standards.
Stayed current on global regulatory guidelines and internal policies, translating updates into practical operational strategies and team SOPs to maintain best-in-class submission readiness.
Represented regulatory operations expertise on global workstreams, regional projects, and Health Authority engagement strategies, ensuring a harmonized approach to global dossier planning and submission.
Led and supported cross-functional collaboration across clinical, non-clinical, safety, and CMC teams to ensure accurate and timely integration of content into eCTD and non-eCTD submissions.
Initiated and managed continuous improvement projects across submission workflows and documentation handling processes, enhancing turnaround times, document quality, and team alignment.
Responsible for maintaining data within the Regulatory Information Management (RIM) system.
Created and archived clinical trial, marketing application submissions, and Health Authority correspondence within BMS's RIM system.
Served as a Data Management SME within cross-functional collaborative initiatives.
Delivered implementation of new processes within Veeva Vault, XeVMPD, IDMP, and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives.
Provided support on creating, running, and analyzing reports for data streamline projects.
Developed and delivered training materials and presentations to a global audience.
Managed Protocol Amendment New Investigator (PANI) submission updates and 1572 forms for FDA submission.
Supported the global data management team with US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods.
Adhered to internal processes, policies, guidelines, SOPs, and training documentation standards.