Polina Zhigalkina

Berufserfahrung von Polina Zhigalkina

• Bis heute 2 Jahre, seit Juni 2022

  Regulatory Affairs Manager

  PSK Pharma Ltd.

  - Supervising projects from development to registration of biological drug products (especially Mabs); - All CTD compilation in accordance with the EMA and EAEU regulatory requirements and supervising a full cycle of bio products registration process; - Support of the registration process including amendments and reply to queries;