Senior/Principal Scientist/Assoc. Director Clinical Research Group

Clinical Research and regulatory documentation Domain Expertise 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, man…