Assoc Mgr Regulatory Publishing

Associate Manager, Regulatory Publishing (BASKING RIDGE, NJ)

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager, Regulatory Publishing (Basking Ridge, NJ) to oversee the formatting and publishing of electronic documents. Manage the building of Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and specifications such as FDA, EMA, and ICH. Ensure quality, accuracy, and submission-readiness, and provide guidance to multidisciplinary teams on developing submission structure strategies as well as good documentation and submission practices. Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures. Identify regulatory system enhancement needs or technical issues and work closely with systems and technical support staff to identify, develop, and implement solutions. Assist with regulatory inspection activities. Provide Document authoring template training, maintain Authoring Template Library, and work with cross-functional teams to develop and maintain templates. Collaborate with vendors who support Regulatory operations related tasks.

Job Requirements:

Requires a Bachelor’s degree in Regulatory Affairs or a related field and 8 years of experience in the job offered or an 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

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