Sergii Podolnyi

Startup and Regulatory Lead (Global)

Farmaceutyka / Biotechnologia

Stare Miasto, Wrocław, Powiat wrocławski

Oferowane usługi

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.

Clinical research

Regulatory manager

Startup operations

Regulatory strategy

Orientacyjna stawka: 40 € za godzinę

Doświadczenie

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