• Deep Regulatory Understanding: Extensive knowledge in EU regulations, directives and guideline. • Expertise in CTC Format: Mastery on CTC Format, with proficiency in compiling and organizing redulatory submission across all modules. • EMA Prodcedure Mastery • Awareness of a wide range of EMA guidelines, regulations and best practices relevant to dossier compilation • Expertise in Regulatory submission tools. • Comprehensive Guideline awareness • Quality Assurance in Relationship. • Experience in EU & US market is must.
