Thassia Roschel's Email Addresses & Phone Numbers

📖 Summary

Associate Director, Retail Pricing @ Sandoz Princeton, New JerseyManager, Pricing & Contracts @ Mayne Pharma • Developed winning pricing strategies with consideration to profitability, generic penetration, market intelligence and price erosion• Managed launch of 5 new generic products (including first-to-file and first-to-market products)• Improved pricing analytics to support business strategy• Improved accuracy and efficiency of rebates accrual process based on deep understanding of current systems functionality • Developed deep understanding of the company’s customers contracts & penalties and competitive issues• Reviewed solicitations and prepared routine response for proposals, bids, and contract modifications meeting deadlines for all submitted RFPs and ROFRs From October 2016 to May 2019 (2 years 8 months) Raleigh-Durham, North Carolina AreaCTA - Clinical Trials Assistant @ Quintiles o Supported the clinical project team in the following areas: update and maintain clinical systems; prepare, handle, distribute, file, and archive clinical documentation and reports; review study files; prepare, handle and distribute of Clinical Trial Supplies and maintenance of tracking information From September 2015 to October 2016 (1 year 2 months) Raleigh-Durham, Carolina do Norte e Região, Estados UnidosPricing Manager @ Novartis • Registered price for 6 products in the Local Health Authority from 4 different Business Units - including conducting pricing negotiation and implementing global strategy• Developed high-level relations with government agencies and other entities of the industry • Re-negotiated higher prices with the Local Health Authority for 2 SKUs and maintained preferred price for one product• Established quality internal relationships which resulted in enhanced synergies (HEOR, Marketing, Sales, Legal, Tax, Business Development)o Regulatory intelligence - reviewed competitors pricing strategy trough price approved/practicedo Managed annual price adjustment as authorized by Health Authorityo Mediated tax reduction processes to obtain the benefit of tax exemption or reductiono Ensured that all internal systems of local and global price are always properly updatedo Developed pricing surveys and performed scenario analysis of product positioning, their likelihood of success and its quantification From July 2013 to April 2015 (1 year 10 months) Government Affairs and Pricing Coordinator @ AstraZeneca • Managed the creation and implementation of Government Affairs strategy • Coordinated the conception of the Pricing organizational structure and procedures• Efficiently monitored legislation related to drug prices and public health policies • Extra project: GXP - Implemented the quality control and compliance system for the regulatory department according to internal regulatory requirements; trained 10 people on the new structureo Actively participated in trade associations pricing committeeso Monitored public health policies focusing on possible partnerships with governmento Ensured adequate support to internal areas as needed (HEOR, Marketing, Sales, Bidding, Legal, Tax, Business Development) From December 2011 to June 2013 (1 year 7 months) Sr Regulatory Affairs Analyst @ AstraZeneca o Prepared and evaluated document packages for regulatory submissions ensuring compliance with local and international regulations, including, but not limited to, NDA, MAA, BLA, CMC and labeling submissions.o Ensured products meet regulatory compliance by supporting regulatory aspects of product approval and post-marketing compliance, recommending changes for labeling and manufacturing-related submissions, including determine acceptability of data, procedures, and other product-related documentso Coordinated the submissions and inspections related to certifications for Good Manufacturing Practiceso Follow-up with health authoritieso Regulatory intelligence - researched information related to product registrations of the company and other companieso Assisted the Bidding departmento Monitored the publication of sanitary laws. From July 2008 to November 2011 (3 years 5 months) Jr Regulatory Affairs Analyst @ Mantecorp o Prepared and evaluated document packages for regulatory submissions ensuring compliance with local and international regulations, including, but not limited to, NDA, MAA, BLA, CMC and labeling submissions.o Ensured products meet regulatory compliance by supporting regulatory aspects of product approval and post-marketing compliance, recommending changes for labeling and manufacturing-related submissions, including determine acceptability of data, procedures, and other product-related documentso Coordinated the submissions and inspections related to certifications for Good Manufacturing Practices From July 2007 to June 2008 (1 year) Jr Regulatory Affairs Analyst @ Pfizer o Coordinated the submissions and inspections related to certifications for Good Manufacturing Practiceso Prepared and evaluated document packages for regulatory submissions ensuring compliance with local and international regulations, including, but not limited to, importation and exportation packages to controlled products From September 2005 to July 2007 (1 year 11 months)