**General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global health authorities. Strong experience with submitting to the EU, US, Canada and Asia Pacific countries in eCTD, NeeS and paper format. **Essential Functions of the job:** + Act as lead publisher when required, for major applications. Provide leadership to plan resources, deliver on strict timelines, track and report submission progress internally and externally, organize appropriate levels of technical support, and actively resolve technical issues. + Responsible for both report level publishing and submission level compilation for global major applications and lifecycle submissions (routine). This includes all document management tasks, creation and qc of all navigation and technical acceptance (e.g. hyperlinking, bookmarking, validation) to ensure submission compliance for Health Authority (HA) acceptance. + Support Regulatory Affairs to deliver high quality and consistent maintenance health authority submissions, through the provision of strategic insight and broad operational level knowledge for those submission types. + Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation. + Represent the Regulatory Operations team on both submission (e.g. Global Filing team) and Regulatory projects teams to provide status and input related to key deliverables (e.g. impact to submission timelines). + Review and contribute to the implementation of standards, templates, and procedures related to regulatory documents, recommend associated process improvements. + Act as mentor to junior resources. + Assist in the evaluation, implementation or upgrade of software, e.g., publishing, validation, viewer or electronic document management systems. + Strong working knowledge of submission requirements and guidelines for all submission types, both paper and electronic and strong experience in the regulatory submission process. + Familiarity with formatting of regulatory submission documents ensuring that documentation meets external and internal company submission-ready standards. + Attention to detail, organized and ability to support multiple simultaneous projects. + Ability to work under challenging deadlines with high quality and consistency. + Ability to work flexible business hours as required to support global submissions within a global Regulatory Operations team. Ability to work beyond core business hours as required. **Qualifications:** + A minimum of 5+ years in the biotechnology or pharmaceutical industry required. + Regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing of major applications, amendments and supplements (manufacturing, nonclinical, clinical). + Experience with CTD/eCTD structure and format. + Strong knowledge of EU, US health authority and ICH regulations and guidance as it pertains to format and submission structure. + Familiar with regulatory requirements for APAC preferred, Canada and other regions desirable. + BA/BS Degree in life science or computer science (with 2+ years of relevant experience) preferred. **Supervisory Responsibilities:** + None **Technical Skills** **:** + Veeva RIM Vault experience required, knowledge of Veeva Publishing preferred. + Experience using eCTD compliant publishing system. + Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness. + Knowledge of MS Word Templates, their function and use. + Working knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks. + Experience with document management and Regulatory Information Management Systems (RIM). **Travel:** Travel as required (Approximately 10%) All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.