Description
not only exceptional technical competency but also superior analysis, problem-solving abilities, leadership, communication and team member experience.
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | (Confidential) | 8/2004 - Present |
| Biomed/Bioma2000 | (Confidential) | 6/2003 - 8/2007 |
| BENEV | (Confidential) | 3/1999 - 1/2003 |
Education
| SCHOOL | MAJOR | YEAR | DEGREE |
|---|---|---|---|
| University of Phoenix | MBA | 2002 | Master Degree |
| California State University of Fullerton | Biochemistry | 1997 | Bachelor Degree |
Accomplishments
Highlights:
Experience Biomed/Bioma2000, Irvine, California Director of Regulatory Affair 2003 Present Provide direction regarding FDA regulation on exporting pharmaceutical Cosmeceutical and Nutraceutical products to overseas. Direct and support product development In Accordance With (IAW) FDA regulations. Communicate with FDA regarding products, filling submission and time negotiations. Communicated and provided information on product approvals and necessary documentations to international regulatory agents. Prepared and organized product evaluations IAW FDA requirements. Prepared and received export and free sale certificates. Provide strategic support and direction on regulatory affairs issues. Evaluate and finalize regulatory reports in compliance with exporting different products to overseas. Evaluate and finalize products for stability testing, packaging and labeling IAW FDA and overseas. Provide technical assistance, and direction to different departments within the U.S and Asia. Train employees on product information, quality and comparison. Maintain regulatory compliances. BENEV Company, Inc., Lake Forest, California Director of Regulatory Affairs/ Research and Development... .1999-2003 Prepared and built Pharmaceutical, Cosmeceutical (functional cosmetics and drugs that are used for topical purposes), and Nutraceutical products. Received drug, cosmetic and dietary manufacture license from FDA. Prepared and received trademark registration for needed products. Provided strategic support and direction on regulatory affairs issues. Managed and prepared ANDA for topical hair solutions to China. Managed and followed up on NDA for topical hair solution in America. Prepared and received free sale and export certificates for China, Japan, and Korea. Registered drugs and functional cosmetics for South Korea and China. Completed the proper documentation for quasi-drug and cosmetic according to the MHW (Ministry of Health and Welfare) in Japan, Korea and China. Prepared and completed Federal inspection document for the purpose of exporting drugs and medical devices. Consulted cross-functional teams on business decisions with regulatory implications. Reviewed and analyzed regulatory impacts of marketing products in different countries of Asia (China, Korea, Japan, Taiwan and Thailand). Prepared nonprofit organization plans for an anti-aging project. Prepared fundraising strategies. Guided activities related to product registration and maintenance including product documents for regulatory filings. Prepared and submitted information consent for product testing from all patients. Evaluated and finalized Cosmeceutical documentation and labeling. Prepared and submitted monitoring study on functional cosmetics Premarket Notification (PMN). Prepared, submitted and received documentation on exporting PMA approved medical device. Headed research and development for functional cosmetic data and documentation. Provided technical assistance and direction to different departments within the U.S and overseas. Implemented training courses for over 31 employees in BENEVs network U.S, Japan and Korea. Represented BENEV product formulary and properties internationally to dermatologists. Audited manufacturing and regulatory documents in U.S., China, Japan, and South Korea. Interviewed and hired employees. Performed annual employee evaluations. 3M, CDI, Inc., Irvine, California Associate Auditor . ... ... .1998-1999 Was responsible for monitoring and investigating device exemption. Auditing heart monitor documentation according to design control of quality system regulation. Responsible for analyzing data and maintaining of it. Prepared and edited medical device documents for clinical drive phase and IDE (investigational device exemption). Evaluated documents for PMA (pre-market approval) package for FDA review. Checked Q.C. files and Protocols for auditing and investigation reports as sponsor-investigator. Maintained regulatory compliances. Beckman Instruments Inc., Brea, California Associate Scientist/Regulatory Affair. .. .. .1996-1998 Team leader for reviewing and evaluating test protocols, system validation, and data analysis that complied with FDA regulations. Prepared medical device documents (510K class III) for investigational device exemptions (IDE) in reference to the protocol and system validation results. Reviewed the software implementation and instrument reports in reference to the medical device and clinical drive phase. Supported software development, validation and implementation for clinical reagents. California State University of Fullerton, California Physical Chemistry Laboratory Assistant (part time) .1993-1996 Assisted professor with protein diffraction preparation. Trained students on different application of computation chemistry. Gathered data and analyzed different types of protein for protein diffraction. JC PENNY, Laguna Hills, California Cosmetic Counter Manager ..1993-1996 Responsible for purchasing (over $50,000 per month), sales and inventory of antiaging Cosmyl products. Introduced and trained employees on new products. Promoted Cosmyl products as a top seller in Southern California branches. Drug Aid Lab, Carlson, California Regulatory Affairs/ Research and Development .1986-1993 Was in charge of contact and communication with European and Asian regulatory agencies for exporting over-the-counter drugs. Prepared and completed the free sale and export certificates for over-the-counter drugs in compliance with FDA regulations for European and Asian laboratories. Communicated with regulatory agents in Europe and Asia for product approvals and necessary documentation. Prepared and organized product evaluations IAW FDA requirements. Introduced and explained different product information to doctors and hospitals.Companies I like:
Companies that have more than 50 employees and been in business for awhile.
Job Skills
Keywords
Responsibilities
I offer a wide variety of skills and business acumen, from extensive research and exemplary understanding of domestic and international business through regulatory affairs. My substantial experience in these areas, knowledge of auditing, domestic and foreign regulation, have all been instrumental in improving production, marketing and sales in all past business endeavors.
