QIANWEN GAN

· Develop and implement regulatory strategies and plans, coordinate cross-functional technical teams (CMC, non-clinical, and clinical) to prepare dossiers, ensure the timely submissions, and follow up with the review process for regulatory activities. Organize the communication meetings with the health authorities (NMPA and/or FDA). Lead applications for CAS number, and INN for the investigational drugs. Provide regulatory support for international cooperation projects, address registration inquiries promptly, and develop domestic registration plans for projects as required by partners. · Lead registration programs including NMPA INDs, FDA INDs, CMC Amendment, communication meetings with NMPA/FDA, FDA DSUR, and FDA ODD submissions. Perform tasks including the organization of dossiers preparation, review, submission, and follow-up of review, with indications covering multiple myeloma, solid tumors, atopic dermatitis, asthma, nasal polyps, and etc. · Coordinate the technical teams to prepare application materials, responsible for dossiers submissions, and communicate with ACS for CAS numbers and WHO for INNs. · Liaise with BD or business partners of international collaborative projects as the representative of the RA Department. Respond to regulatory related inquiries promptly. Develop domestic registration plans for projects as required by partners, and provide support for the global R&D of investigational drugs. · Create regulatory affairs relevant work instructions to provide guidance for the team and improve the overall application efficiency, such as application processes for FDA ODD, Fast Track, and amendments. · Assist clinical PM in completing CDE clinical trial registration.

Compile and maintain regulatory documentation databases or system. Prepare and submit FDA and NMPA IND regulatory documentation in compliance with regulatory requirements. Act as the project manager and key client contact on assigned projects. Responsible for effective communication with the functional departments and clients to ensure the project runs smoothly. Provide regular updates regarding the status and progress of projects.

· Responsible for performing QA/RA related tasks such as developing QA policies and procedures for quality departments, draft and review quality related SOPs base on NSF cGMP guideline, handling customer complaints, qualifying raw material vendor, participating in investigations, preparing for Corrective action and Preventive Action (CAPA), and disposition of raw materials within the quality department of a $26M organization in the dietary supplement industry. · Evaluate MTC standard procedures, develop quality standards and procedures for quality departments such as Foreign Supplier Verification Program (FSVP) plan, food safety plan. Draft and review quality related SOPs based on cGMP requirement, such as SOP for vendor qualification and disqualification, SOP for change controls, SOP for investigation, SOP for Corrective action and Preventive Action, Specification for carton label, pallet, etc. · Responsible for handling customer complaints, participating in investigations, preparing CAPA, and disposition of raw materials. · Involve in API & raw material vendor qualification and selection to ensure meeting quality and regulatory compliance. · Provide technical consultation and regulatory support to purchasing, sales and international clients. · Initiate and manage Kosher program. · Coordinate with 3rd party agencies in pre-market approval. (CFDA “Blue Hat” dietary supplement registration) · Apply government certificates/permits. (FDA Free Sale Certificate, USDA Veterinary Science Permit)

· Responsible for performing QA/RA related tasks such as developing QA policies and procedures for quality departments, draft and review quality related SOPs base on NSF cGMP guideline, handling customer complaints, qualifying raw material vendor, participating in investigations, preparing for Corrective action and Preventive Action (CAPA), and disposition of raw materials within the quality department of a $26M organization in the dietary supplement industry. · Evaluate MTC standard procedures, develop quality standards and procedures for quality departments such as Foreign Supplier Verification Program (FSVP) plan, food safety plan. Draft and review quality related SOPs based on cGMP requirement, such as SOP for vendor qualification and disqualification, SOP for change controls, SOP for investigation, SOP for Corrective action and Preventive Action, Specification for carton label, pallet, etc. · Responsible for handling customer complaints, participating in investigations, preparing CAPA, and disposition of raw materials. · Involve in API & raw material vendor qualification and selection to ensure meeting quality and regulatory compliance. · Provide technical consultation and regulatory support to purchasing, sales and international clients. · Initiate and manage Kosher program. · Coordinate with 3rd party agencies in pre-market approval. (CFDA “Blue Hat” dietary supplement registration) · Apply government certificates/permits. (FDA Free Sale Certificate, USDA Veterinary Science Permit)

• Responsible for performing QA/QC and basic regulatory affairs related tasks such as writing regulatory letters to FDA, applying FDA free sale certificate, amending food dietary products’ label based on regulatory requirements, performing new, renew and amendment of food facility registration, collecting and reviewing statements from vendors, contacting Kosher agencies to update Kosher certificate, drafting and reviewing SOP based on GMP, working with 3rd party labs to ensure product meet the required specification within the technical department of a $25M organization in the dietary supplement industry.

Advisor: Prof. Iwao Ojima Structure-activity relationships (SAR) study of α/γ-truxillic acid-based fatty acid binding protein inhibitors as anti-nociceptive and anti-inflammatory drugs • Synthesized and purified five truxillic acid intermediates and six final compounds through multistep synthesis. • Characterized intermediates and final compounds by NMR, ESI-MS, HPLC, melting point. Design and development of small molecule inhibitors of matrix metalloproteinase 9 • Modified reaction condition and synthesized six final compounds with high purity through multistep synthesis. • Characterized intermediates and final compounds by NMR, ESI-MS, HPLC, melting point.

• Successfully developed and validated HPLC methods for the detection and quantification of RF201401 as part of a team. • Practiced maintenance on laboratory equipment including HPLC, IR, and replenish laboratory supplies. • Wrote records of all experiments and observations, submitted periodic reports.

• Collected the technical materials such as the ingredient and quality standard of related crude drugs. • Surveyed and drew the sketches of production technology process, energy-saving measures, pipe connection methods.

Structure-activity relationships (SAR) study of α/γ-truxillic acid-based fatty acid binding protein inhibitors as anti-nociceptive and anti-inflammatory drugs • Synthesized and purified five truxillic acid intermediates and six final compounds through multistep synthesis. • Characterized intermediates and final compounds by NMR, ESI-MS, HPLC, melting point. Design and development of small molecule inhibitors of matrix metalloproteinase 9 • Modified reaction condition and synthesized six final compounds with high purity through multistep synthesis. • Characterized intermediates and final compounds by NMR, ESI-MS, HPLC, melting point.

Major in Pharmaceutical Engineering. Recieved Second Scholarship of Wuhan Institute of Technology. Patent of “Optimization of the One-step Technology of Compounding Nitazoxanide”.