Artur Shchukin, MS, CQA, RAC

Lead the Regulatory Affairs efforts: • Writing, preparing, compiling, reviewing and managing all regulatory submissions and filings required for the FDA and all other governing authorities • Developing proactive regulatory strategies • Reviewing and approving promotional materials and advertisement • Development and preparation of CMC sections of the regulatory submissions including NDA's, MAA's, INDs, CTAs • Monitoring the impact of changing regulations on submission strategies and update internal stakeholders • Ensuring compliance with product clinical and post marketing approval requirements • Serving as the primary contact for all regulatory and governing agencies. • Lead sites qualification processes

Lead the Regulatory Affairs and Quality Assurance efforts of Zionexa US: • Writing, preparing, compiling, reviewing and managing all regulatory submissions and filings required for the FDA and all other governing authorities • Developing and executing company's procedures and processes • Monitoring the impact of changing regulations on submission strategies and update internal stakeholders • Monitoring applications under regulatory review • Ensuring compliance with pharmacovigilance and product post marketing approval requirements • Serving as the primary contact for all regulatory and governing agencies.

Responsible for all aspects of clinical research regulatory compliance, including document preparation, submission and management for a specified portfolio of clinical trials: • Prepare and submit IND/IDE applications, modifications and annual reports to FDA • Support nine principal investigators and execute their varying research priorities in a portfolio which includes investigator initiated trials, NIH funded cooperative group trials, industry sponsored trials, and transitional research • Ensure that all clinic care and research adheres to hospital, protocols, SOPs, and regulatory requirements (GCP, ICH, FDA, IRB) • Perform compliance audits of protocols • Ensure proper study startup, execution, conduct, and closure that is in compliance with GCP, institutional standards and other regulatory standards • Implement study startup through conception, internal committee reviews, budget/contract negotiations, IRB submission up to the Site Initiation Visit. Acts as a liaison between PI, FDA, internal committees, sponsors, and staff • Full board IRB member • Review and assist in budget and contract negotiations, and overall program finances • Oversee and manage audits from sponsors and regulatory bodies • Provide input to the Resource Allocation Committee on the feasibility of conducting new trials involving cellular therapies • Compose, amend and maintain regulatory documents and SOPs (e.g. ICF, protocol) • Prepare SAE and IND Safety Reports for IRB and FDA submissions • Prepare and participate in Study Initiation Visits and Interim Monitoring Visits • Mentor, train and review the work of less experienced clinical research staff

Management representative responsible for safety and compliance with US and global regulations of API, drugs, food and hazard materials: • Ensured company’s compliance with FDA cGMP, ICH, USDA, OSHA GHS, and CBP policies • Consulted global manufacturers on US, and Global regulatory requirements (e.g. eSubmissions, Risk Management, GRASE, HACCP, and GHS) • Company regulatory submissions: DMF, ANDA, drug listing, drug establishment registration etc. • Ensured products compliance with requirements of international customers such as Pfizer, GlaxoSmithKline, and Merck • Conducted operational, financial and compliance audits of domestic and foreign suppliers • Ensured smooth import process of hazardous materials with FDA and CBP • Obtained and manage State and Import licenses and permits as required • Monitored Corrective and Preventive Plans execution

Ensure the center compliance with FDA cGMP, ICH/GCP, GTP, HIPAA, and DOH policies • IND Electronic Submissions and life cycle management of these submissions in eCTD • Conducting compliance audits of Donor (Suitability) Eligibility System, Product Testing System, Quarantine/Inventory Management System, Production and Processing System • Monitoring Quality Incidents and Adverse Events during clinical trials • Serving as QA interface to the NMDP, the FDA and DOH • Identifying and leading continual improvement project with cross functional team members • Corrective and Preventive Action root cause analyses • Specific expertise in: 21 CFR Parts 210, 211, 312, 640, 1271.

Maintained ISO 13485, ISO 9001, FDA cGMP, MDD, and CMDR compliant Quality Management System • Conducted customer complaint and product return investigations • Member of the R&D team which obtained 510(k) approval for Steam Dot Blu Process Indicator • Prepared Technical Master Files for device and combination products • Evaluation of nonconforming product and determination of final disposition • Corrective and Preventive Action root cause analyses • Coordination of interdepartmental investigations and action plans • Internal audits of Sterile and Quality Management System processes • Control of calibrated measuring and test equipment, including capital equipment • Supervised and assisted Quality Control personnel • Verification and maintenance of product quality for entire product line • Ensured product conformity to recognized consensus standards, including ISO 11138 and ISO 11140 • Formulation of solutions used in the development and manufacture of occult blood tests • Analysis of metrics and preparation of trend reports for Management Review Meetings

• Shadow Emergency Room Physician and assist in a variety of tasks

• Juvenile Mouse Lead Project – research study which analyzed the influence of heavy metals (e.g. lead) on bone structure

• Used Computer Numeric Control(CNC) software to create custom parts according to specifications • Installed assemblies in supportive frameworks • Determined project requirements, including scope, sequence, methods, and materials, according to blueprints, drawings, and written instructions