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Associate Manager, Regulatory Publishing (BASKING RIDGE, NJ) Regeneron Pharmaceuticals, Inc. seeks an Associate Manager, Regulatory Publishing (Basking Ridge, NJ) to oversee the formatting and publishing of electronic docs and manage the building of regulatory submission deliverables. Requires Bachelor’s degree in Regulatory Affairs or related field and 8 years of experience in the job offered or acceptable alternate occupation. Experience must include: electronically formatting and publishing clinical, nonclinical, CMC and regulatory documents; publishing in eCTD format Initial INDs, Original BLAs, sBLAs, and all other maintenance type Regulatory submissions to FDA in the pharmaceutical industry; advanced knowledge of Veeva Vault RIM, Extedo eCTDManager, GlobalSubmit Review and Validate, ISI Toolbox, Liquent Smartdesk, and Liquent Insight for Viewing; and working knowledge of nonclinical and clinical data standards (ADaM, SDTM, SEND). Less than 10% domestic travel required. Apply at https://careers.regeneron.com, reference code R6261
