Sujit Gaddampally

About Sujit Gaddampally

With over a decade of regulatory affairs experience, I currently serve as Manager-II, Regulatory Portfolio Management at Bristol Myers Squibb. I specialize in authoring and reviewing regulatory documents, supporting global and U.S. regulatory leads, and preparing critical submissions. My work involves collaborating on FDA meetings, pediatric study plans, and regulatory precedence research to ensure compliance and readiness for regulatory engagements. Proficient in tools like Veeva, SAP, SARA DMS etc. I contribute to seamless operational workflows and global compliance. My expertise in document and project management enables effective coordination with stakeholders, fostering collaboration to meet market-specific regulatory requirements. Committed to excellence, I support the organization’s mission to deliver impactful and strategic regulatory solutions worldwide.

Experience

1. Manager - Ii - Regulatory Portfolio Management

   百时美施贵宝

   Jan 2024 — Present · Hyderabad, IN

   Partnering with Global Regulatory Lead (GRL) and U.S. Regulatory Lead (USRL) to ensure thorough and compliant submissions.• Authoring, compiling, and publishing Module 1 documents; reviewing dossiers for accuracy and completeness prior to submission.• Supporting GRL/USRL with FDA meetings and pediatric study plans in both the USA and Europe.• Conducting regulatory precedence research, analyzing past FDA feedback, and educating teams on potential Advisory Committee meetings.• Preparing critical regulatory components such as General Investigation Plans (GIP), Safety and Development Study Plans (SDSP), global marketing authorization status reports for aggregate safety updates, and orphan drug annual reports, ensuring timely submissions to IND/BLA/NDA as needed.• Managing regulatory actions, including withdrawing INDs, preparing Letters of Authorization, submitting notifications of serious breach, and developing summaries for root cause analysis and CAPA plans.• Facilitating Rapid Response Team meetings to coordinate prompt, high-quality responses to global health authority queries, including for EU Clinical Trial Regulation (EU-CTR) member states.• Maintaining comprehensive global regulatory records, including tracking milestones, health authority interactions, and post-approval commitments using Veeva Vault and CARA/PRISM.• Collaborating cross-functionally to strategize and ensure timely submissions, mitigating potential delays.

Education

• The University of Huddersfield

  Master’s Degree, Pharmaceutical Sciences

  2010 — 2012

• Jawaharlal Nehru Technological University

  Bachelor’s Degree, Biotechnology

  2005 — 2009