Technical Skills: Good grasp of pharma regulatory practices, CMC, ICH guidelines, and market specific requirements (Asia, LATAM and Africa) Experience in dossier gap assessment Proven authoring capabilities in CTD and ACTD formats (Modules 1, 2, and 3) Ability to draft well-reasoned responses to client and authority queries Familiarity with ROW market-specific regulatory expectationsSoft Skills: Excellent communication and writing abilities Collaborative, adaptable, and proficient in multitasking Strong time management and emotional intelligence