Spyridon Dimopoulos

WORK HISTORY

EDUCATION

SKILLS

ABOUT SPYRIDON DIMOPOULOS

Senior Regulatory Operations Publishing Manager with extensive hands-on experience in creating eCTD, NeeS, ASEAN, and Paper submissions across diverse therapeutic areas, including Consumer Health, Oncology, Respiratory, Pain, and more. Proven track record managing regulatory submissions across Europe, Asia, the US, and Latin America. Expert in national, centralized, decentralized, and mutual recognition procedures, with experience in publishing dossiers involving multiple drug substances.Regulatory Document Specialist / Publisher, adept at compiling complex, high-volume documents that integrate graphics and technical content across industries such as pharmaceuticals, aerospace, and engineering. Strong decision-making, analytical, and problem-solving skills. Exceptional team player, skilled at coordinating multiple projects with precision and accuracy. Known for effectively liaising with internal departments, subject matter experts, and target audiences to incorporate their concerns and requirements into high-quality regulatory documents.As a creative and energetic Document Specialist, I specialize in preparing large, complex regulatory documents. I have provided technical support and review for regulatory submissions, including Clinical Study Reports (CSRs), electronic Common Technical Documents (eCTDs), clinical trial protocols, and more. Notably, I worked with GSK on the completion of a New Drug Application (NDA) submission to the FDA, one of the largest eCTD submissions ever received by the agency. My responsibilities included compiling, publishing, and quality-checking documents such as CSRs, appendices, protocols, amendments, Investigator Brochures (IBs), and other regulatory materials. I also created and maintained a bibliographic reference library of 3,500+ published references.Additionally, I have a strong background in Field Service Electronics and Telecommunications Engineering, with experience troubleshooting and working at the component level.