Profile

Artur Shchukin, RAC, MS, ASQ-CQA

Contact Details

Bronze Member
RegEx Pro

Bio

Self-directed and adaptable Regulatory Affairs and Quality Assurance professional with experience in the Pharmaceutical, Clinical Trial Management and Medical Devices industries. ASQ CQA and Clinical Trials Management certified with expertise in providing independent advice and consultation for the interpretation of regulatory requirements, regulations and quality management systems on an international level. Experienced in auditing, regulatory eCTD submissions (IND, ANDA, NDA, BLA), clinical trial and technical product management and development, document consolidation, process improvement and streamlining, and the development of company-wide safety protocols and business continuity plans. BA in Chemistry and MS in Regulatory Affairs & Quality Assurance.

Education

Temple University School of Pharmacy
United States
MS, Regulatory Affairs and Quality Assurance
Regulatory Affairs

CUNY Brooklyn College
United States
BA, Chemistry
Chemistry

Year Entered Profession

  • 2010-2014

Current Organization Type

  • Industry Organization

Job History

Regulatory Compliance Manager
New York, NY, United States
October 2017 - present

Director, Regulatory Compliance
New York, NY, United States
April 2015 - October 2017

Manager, Quality Assurance
New York, NY, United States
January 2013 - April 2015

RA/QA Specialist
Long Island City, NY, United States
September 2011 - December 2013

Research Contributor
Brooklyn, NY, United States
January 2010 - January 2011

Highest Degree Earned

  • Masters

Regional Interests

  • Canada
  • Europe
  • Japan
  • Russia
  • US
  • Worldwide

Product Interests

  • API's
  • Biologics
  • Biosimilars/Generic
  • Combination Products
  • Generic Drugs
  • Innovative Pharmaceuticals
  • Orphan Products
  • OTC drugs
  • Other
  • Veterinary medicines