Sergii Podolnyi

Start up and regulatory manager with over 15 years in clinical research, specializing in start-up operations and regulatory strategy. Proven success leading multinational teams and regulatory for trials across Europe and globally.

• Coordinated submission strategy Globally (EUCAN, GEM, APAC, Americas) for studies in various therapeutic areas including oncology protocols, rescue studies, rare disease.
• Contributed to regulatory submission strategy for clinical trials, including CTA planning and lifecycle management, cross-functional meetings and follow-up actions.
• Executed and oversaw end-to-end CTA process in alignment with FDA and EMA requirements (CTAs, INDs, MAAs, PIPs). 
• Ensured cross-department alignment, project deliverables, milestones, and interdependencies between Regulatory, Clinical, and Business Development teams.
• Acted as main contact for health authorities and project teams during the application process.
• Tracked submission timelines, KPIs metrics and ensured eTMF completeness for all CTA activities 
• My team's performance directly contributed to bringing a new client for the company.
• Delivered internal regulatory training on CTIS and Veeva Vault processes.
• Ensured full compliance with ICH-GCP and sponsor SOPs.
• Contact me for details, 20 years of working experience in different areas

MA in English teaching and interpreting