• Possess over 13 years experience working in a cGMP environment in clinical (R&D) as well as commercial support. Experience working in entrepreneurial as well as CRO environment. • Certificate in QA/RA Drug Development program from Temple University. Possess a thorough understanding of the Drug Development process as well as cGMP and GLP regulations and ICH guidelines. • Currently pursuing Masters of Science at Northeastern University (online) for Masters of Science in Regulatory Affairs • Cross-trained in Quality Assurance and CMC Regulatory Affairs. Authored sections of Common Technical Document (CTD) for Module 2 and Module 3. Support Health Authority inspections and performed document review. • Experience conducting laboratory investigations, laboratory audits, instrument IQ/OQ/PQ and writing research reports, investigation reports, method validation protocols and reports and instrument validation protocols and reports in support of CMC regulatory submissions.