Premlata Gunapu

I’ve spent my career at the intersection of science, strategy, and execution- helping organizations navigate complexity and make confident regulatory decisions that move programs forward. With 15+ years in global regulatory affairs, I’ve led strategy from early development through approval and lifecycle management.Proven impact in complex, high‑stakes situations-high‑priority assets, evolving data, and challenging regulatory environments-bringing clarity, alignment, and momentum when it matters most.Track record includes Gammagard Liquid (CIDP) approval, FDA strategies enabling resubmissions, and key contributions to RYBELSUS and OZEMPIC, alongside multiple IND programs.My core areas of focus include global regulatory strategy, FDA and international health authority interactions, IND/NDA/BLA submissions, labeling and AdComm preparation, and lifecycle planning across immunology, rare disease, and metabolic portfolios. Across roles, I’ve partnered closely with clinical, commercial, and executive teams to ensure regulatory strategy is aligned with broader portfolio goals.I’m motivated by elevating regulatory into a strategic lever-accelerating development, managing risk, and bringing therapies to patients faster-while developing high-performing teams and influencing key decisions.