Hana Petrakova

Developing executable regulatory strategies for new registrations, variations, and renewals across global markets. Authoring and quality-checking CTD Module 3, performing dossier due diligence, and ensuring data accuracy within RIM systems.

Contributed to global deployment of Veeva Regulatory Vault as Local RA Subject Matter Expert, gathering business requirements and participating in system configuration. Managed local regulatory activities including submissions, translations, and MAH transfers, and served as RIM Ambassador.

Managed global change controls and regulatory impact assessments for lifecycle management, translating changes into submissions across 20+ markets. Collected and quality-checked CMC documentation, performed gap assessments, and supported GMP audits.

Developed regulatory strategies for new registrations, variations, renewals, and transfers across EU and non-EU markets. Managed critical regulatory projects, prepared CTD modules, and supported EDMS deployment.

Coordinated regulatory affairs activities, supporting submissions and compliance across markets. Assisted in preparation of regulatory dossiers and documentation.

Managed a 5-person RA team, compiled regulatory dossiers for bioequivalence studies, and supported clinical trial submissions. Led harmonisation of 70 legacy dossiers to CTD and EDMS implementation.

Managed regulatory affairs activities including variations, renewals, and CTD module compilation. Led EDMS and eCTD publishing tool deployment within the RA function.

Compiled CTD modules, prepared eCTD submissions, and supported EDMS implementation. Managed EU submissions for new registrations, variations, and renewals.

Ensured compliance of food and cosmetics products with Czech regulations, including product label review.

Earned an Engineer's degree (equivalent to MSc) in Food Chemistry and Technology from the University of Chemistry and Technology, Prague, from 1997 to 2002.