Toxicology & Regulatory Position |
| 03-15 20:15:18 来源： 作者： |
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Toxicology & Regulatory Position Inquiry (采购产品): Toxicology & Regulatory Position 10/23/2006 Dear Sir/Madam, I am currently looking for a position (preferably full time, or contract) in Toxicology/Regulatory Affairs/EH&S and other related areas in the Connecticut area. My experience and expertise in Global regulations, Toxicology & Risk Assessment, Regulatory compliance, and other EH&S related areas are outlined below. Toxicology & Risk Assessment Study Monitor for Toxicology testing at Contract Research Organizations Global Regulations including EU REACH TSCA/EU/OECD/MITI/TGD/Environment Canada/China, Korea, Philippines, etc. Product Safety & Regulatory Compliance Chemical Notifications (PMN)/Registration Chemical Classifications & Labeling, GHS, EU Risk and Safety Phrases, WHIMIS, Marine pollutants.etc. PBTs & CMR Environment, Health & Safety of chemicals MSDS' Pesticide registration Analytical Chemistry GLP Regulations Quality Assurance and Quality Control. Customer requests/concerns. I am a confident, creative, results oriented, hard working and disciplined individual who promptly delivers the results and never hesitate to take challenging tasks and complete them satisfactorily. I am independent and dependable and do not hesitate to go the extra mile and I am very passionate in the work I undertake. The attached curriculum vitae, discusses my experience and expertise in the various fields. I look forward to discussing further my capabilities and how I can be of help. Thank you. Rama Vithala, Ph.D. Tel: 860-674-0056 e-mail: 2vithala@sbcglobal.net ---------------------------------------------------------- Rama V. Vithala, Ph.D. 15 South Ridge Road Farmington, CT 06032 USA Phone (860) 674-0056 (Home) e-mail: 2vithala@sbcglobal.net U. S. CITIZEN Areas of Experience & Expertise Toxicology – Mammalian, Ecotoxicology, Environmental Fate, Chemical Risk Assessment, Regulatory Affairs, Regulatory Compliance, Quality Control/Quality Assurance, Analytical Chemistry . Regulatory: EU, REACH, USA TSCA, FIFRA, Canada, Japan, China, Global Notifications, Risk Assessment, HPV and EHPV, OECD, SIDS, SIAR, IUCLID, EPISUITE, MSDS, Classification/Labeling including GHS, etc. Work Experience October 2011-Present –SI Group (formerly Schenectady International) Manager, Toxicology & Regulatory Affairs Responsible for managing and monitoring Ecotoxicology and Mammalian toxicology work at CRO labs for global Notifications & Registrations of chemicals. Continue to work on HPV & EHPV Robust Summaries/Test plans. Involved with the development of SIDS & SIARS for EU and other nations. Work with Trade Organizations and also independently submit regulatory reports. Coordinate with EU Competent Authorities, Environment Canada, US EPA, etc. Coordinate TSCA 8(e) submissions to the EPA Knowledgeable of Environmental Toxicology (Soil leaching, Ground water and sediment issues, Water quality criteria, sediment quality criteria, etc.). Mammalian Tox (Oral, Eye Irritation, Dermal, Repeat Dose, Repro/Devpt Tox, Dermal penetration, Mutagenicity, Carcinogenity, etc studies), Ecotox (Fish, Algae, Daphnia, Fish life cycle analysis, Soil/Sediment Toxicity), Regulatory: REACH, OECD, US EPA TSCA, IUCLID, SIDS, SIAR, Robust Summary/Test Plan. MSDS: Helped with MSDS' including the classification and labeling such as the 'Risk' and 'Safety' phrases, WHIMS classification, etc. Also helped with the DOT, IATA, ADR, TGD, Marine pollutant regulations. Nov. 1992 -July 2005 Chemtura Corporation (previously Crompton Corporation and Uniroyal Chemical). Dec. 2001 - July 2005: Regulatory Toxicologist (EH&S) o Toxicology Studies: Contracted and monitored toxicology studies (PhysChem/ Environmental and Mammalian) following GLPs', TSCA, OECD and MITI guidelines and SOPs' at various contract facilities in US, Europe, Japan and India. Helped in the design of the study plan to ensure global acceptance of the studies. Identified labs that do quality studies at a lower cost, there by saving hundred of thousands of dollars. o Classification: Reviewed study results and classified the data following global regulations and country specific requirements, including the EU 'Risk and Safety' phrases o HPV Chemicals: Monitored HPV studies for consortia and Orphans. Prepared IUCLID documents and submitted to the US EPA and ICCA. Saved hundreds of thousands of dollars by placing some of the orphans in consortia after category justification, eliminating sold/no longer made by Crompton Corporation for HPV chemicals committed in 1990. o Existing Chemicals: Prepared SIARS and submitted to the EU regulatory agencies. o Risk Assessment: Prepared dossiers and participated in the risk assessment meetings. The comments by the various EU rapporteurs were responded and made appropriate arguments to defend Chemtura's products. Chemical Notification/Registration: Coordinated with the respective departments and helped in the preparation and submission of dossiers for new chemicals worldwide. MSDS: Helped with MSDS' including the classification such as the 'Risk' and 'Safety' phrases, WHIMS classification, etc. Regulations: Continue to keep up-to-date on the ever changing global (particularly US, EU, Australia, Canada, Japan, China, Korea, Philippines) regulations. New Products: Performed structure activity relation on new chemicals that had a potential to be marketed. This helped in picking the right chemicals that are accepted globally and minimized the cost by avoiding unnecessary testing. Familiar with EPIWIN, ECOSAR and Fugacity modeling programs. New Regulations to be implemented soon REACH - Identified products that are PBT (Persistent/Bioaccumulative/Toxic) and CMR (Carcinogen/Mutagen/Reprotoxins) chemicals to get a head start on preparing for REACH. Canada DSL/NDSL PBT chemicals - Reviewed chemicals that are classified as 'PBT' as this new regulation will be in effect starting 2006. Japan PBT - Japan is in the discussion stage of how to deal with the PBT chemicals. I can help by reviewing the chemicals and be prepared when the regulation kicks in, thereby saving the products. EHPV - Expanded High Production Volume chemicals is a continuation of the HPV program and I can identify non-sponsored HPV chemicals and try to place them in consortia, thereby saving hundreds of thousands of dollars. August 1996-Nov. 2001: Manager, Analytical Services Responsible for managing a group of 6 people conducting work on LC-MS; GC-MS, Analytical Standards Characterization, Metabolism/Environmental Fate/Product Chemistry studies, Combustion work, Shipment of Analytical standards worldwide and, Hazmat coordinator for the Registration Chemistry Section. I conducted yearly performance evaluations including career development for all associates in the group. Nov. 1994 - August 1996 : Group Leader (Crop Protection Chemicals) Study Director for Product Chemistry, Environmental Fate and Plant Metabolism studies conducted in-house and Study monitor for studies contacted to outside labs. Responsible for Analysis/validation of analytical methods. Nov 1992-August 1996: Research Scientist - Environmental Chemistry Crop Protection R&D Designed and conducted various environmental toxicology studies at Chemtura Corporation. Also, contracted work to contract labs and monitored the studies. June 1988 -Nov 1992: Center for Hazardous Materials Research (Pittsburgh, PA) Research Scientist Study Director for FIFRA Environmental fate studies for Pesticides following Good Laboratory Practice standards: Responsible for writing several SOPs, and general and chemical specific protocols for various environmental fate studies including field dissipation studies. June 1988 -Dec 1986: Dynamac Corporation, Rockville, MD Staff Scientist Evaluated industrial and government reports on environmental fate of pesticides for scientific validity and meeting FIFRA regulatory data requirements for EPA's pesticide registration. Analyzed and edited pesticide data concerning hydrolysis, photolysis, metabolism, field dissipation, soil leaching, crop rotation, and residue accumulation in crops and fish. January 1986 -November 1986 University of Florida, Citrus Research Center, Lake |
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