Polina Zhigalkina
Angestellt, Regulatory Affairs Manager, PSK Pharma Ltd.
Skills
Timeline
Professional experience for Polina Zhigalkina
- Current 3 years and 10 months, since Jun 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;
Languages
Russian
First language
English
Intermediate
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