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Regulatory Affairs Analyst

Company Name:
Lancesoft Inc
Perform analysis of regulatory eCTD, PCO DMF and Medex documentation. Review in-depth CMC content in the electronic document management system for registered products. Analyze the process change request and variations to be implemented. Create the CMC content as per regulatory requirements for different markets all around the world. Review and access product change control and ensure that it is reflected in the currently registered data for Pharmaceutical Products. Perform Regulatory Action Notification Analysis for any Post approval changes to include Renewals, Annual reports, Market registration, supplements/variations and responses for US and rest of the world. Use the internal DCP data base system and share point site. Analyze new and existing internal Client CMC systems for change control, document authoring, project management and quality information provided to release sites. Master's degree plus college level coursework in Drug and Medical Device Regulation and Practical Aspects of Regulatory Compliance is required. Work site: Short Hills, NJ. Send resume to:

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