Poojitha Kothapalli

Background

About Poojitha Kothapalli

I’m an experienced Analytical Scientist and Regulatory CMC professional with over 9 years in the pharmaceutical and biotech industry, contributing to the successful development and global registration of small molecules and biologics. I bring deep technical expertise in analytical method development, validation, stability support, and regulatory documentation across all phases of drug development (IND, NDA, ANDA, IMPD).My core strengths include: • Method development/validation and stability data evaluation for clinical and commercial products • Authoring and reviewing analytical content in Module 3 (IND/NDA/BLA/IMPD) and CTA documents • Supporting analytical activities at CDMOs, including method transfer, validation protocol/report reviews, and troubleshooting • Experience with regulatory submissions across US, EU, and other regions, including pre-IND, EOP2, and HA meeting prep • Skilled in writing specification justification, stability summaries, method equivalence reports, and QOS/JOS sectionsI’m also well-versed in regulatory publishing tools such as Acumen, StartingPoint, and ISI Toolbox (Modules 4 & 5), as well as eCTD formatting, hyperlinking, bookmarking, and label proofreading. Additionally, I hold a Base SAS9 certification and possess foundational knowledge in SAS as part of my training.I’m known for my attention to detail, cross-functional communication, and strong documentation practices aligned with FDA and ICH guidelines. I thrive in fast-paced, science-driven environments and enjoy contributing to projects that impact global health. I’m passionate about ensuring scientific integrity and regulatory compliance in every step of the product lifecycle.