Olga Solovyeva

Experience

• 

  Nizhny Novgorod State Medicine Academy (NizhGMA)

  Sept 2016 - Jun 2018

  Assistant
• 

  Bayer

  Jul 2018 - Jun 2019

  Regulatory Affairs Intern

  • Preparation of the registration dossier (PIL, statements) in the frame of EAEU submission• Registration dossiers preparation for the submissions and variations and their submission to the competent national regulatory authorities;• A comparative analysis of the pharmacopoeial requirements for dosage forms according to the National and European Pharmacopoeia was performed. • Support of registration procedures in CIS countries• Calculates and orders samples and reference standards required for quality testing of pharmaceuticals.• Review of normative documentations, mock-ups for print-release and promotional materials Show less

• 

  Novartis

  Jun 2019 - Feb 2023

  • Implementing regulatory strategy and managing operational activities in frames of new registration processes (chemical, oligonucleotide DPs and gene therapy) and harmonization projects in EAEU region• Managing the process of normative documentation, national prescribing information and artworks creation• Facilitates preparation of departmental guidelines for EAEU purposes. • Develops and implements plans for timely response to HA requests and coordinates responses to avoid/minimize clock stops during submission review• Contributes to development of departmental goals and objectives Show less

  • Sr. RA specialist

    Jan 2022 - Feb 2023

  • RA specialist

    Jun 2019 - Jan 2022
• 

  AstraZeneca

  Jan 2023 - now

  RA Rare Disease Manager