Years of experience: 13
🧨 Consulting✨ Business OwnerChemist PharmacistService ProviderRegulatory Affairs SpecialistQuality Assurance Specialist
Trust Score
Highly reliable; strong professional involvement.
Zhanna's Career Path
Mar. 2019 -Present
Accelsiors CROJunior Regulatory Affairs Manager
Yerevan, Armenia1. Overseeing preparation, review and submission of clinical trial regulatory documents and responses to questions to central authority (Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other authorities for the assigned country/countries) and ensuring submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines. 2. Re...
Mar. 2017 -Aug. 2018
FMD K&LRegulatory Affairs Specialist / Project Team Lead
Yerevan1. Monitored the processing of Requests by Team and supported the team members to resolve issues.
2. Updated Regulatory Information Management System (for drugs with marketing authorization) based on Requests submitted by the Project Business User.
3. Performed activities to take information from Requests and populate in Validated Software System. 4. Processed new, copy and update Requests, m...
May. 2013 -Mar. 2017
ARPIMED LLCHead of Quality Assurance Department
c. Abovyan, 2204, Republic of Armenia1. Developed and implemented the Quality department’s strategy, to ensure it met the business requirements and customer deliverables, as well as ensured the departmental performance against goals. 2. Implemented and monitored all Quality Assurance systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use.
3. Acted as the main point...