Regulatory submission expertise across CTD/eCTD formats — deep familiarity with the Common Technical Document structure (Modules 1–5) and how CMC (Module 3), nonclinical/toxicology (Module 4), and clinical (Module 5) sections fit together.
Experience preparing submissions for FDA (NDA/BLA/ANDA), EMA, and other ICH-aligned agencies.
Hands-on experience drafting or reviewing CMC sections (drug substance/ product specs, stability, manufacturing)
Hands-on experience in nonclinical toxicology reports/summaries and understanding submission gaps.
—Working knowledge of ICH Q (Q1–Q14), S (S1–S12), E (E1–E20), and M (M4, M8) guidelines (ICH guideline fluency (Quality, Safety, Efficacy series) ) and the format and content expectations across US/Europe and Asian markets.
Track record supporting drug expansion into new regulatory jurisdictions (US, EU, and others), including gap analyses between regional requirements and adapting dossiers accordingly.
Provide subject matter expertise on clinical trials, drug development, and clinical research processes to the Science, AI, Data Science, and Software Engineering teams to develop clinically relevant products and features.
Support the design, development, validation, and enhancement of clinical research products and platforms.
Review and validate clinical workflows, protocols, study designs, and research methodologies used in products and customer solutions.
Provide insights on industry trends, regulations, and best practices in clinical research.
Provide expert knowledge for the development of algorithms, data models, and clinical decision-support applications.
