Senior Regulatory Publisher

Job Description

Job DescriptionThe Contract Regulatory Publisher’s primary role is to provide document and sequence level publishing and compilation for US, EMA and RoW regulatory submissions.This role also provides support for the planning, acquisition, preparation, compilation, quality control (QC), retention and submission of regulatory documents to US and ex-US health authorities. He/she ensures that documentation and submissions are complete and are in compliance with relevant health authority requirements (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), company Standard Operating Procedures (SOPs), and other directives to allow for initiation of clinical trials and subsequent marketing authorizations. He/she maintains regulatory submissions, health authority correspondence, and relevant documentation in an appropriate archive location in accordance with regulatory guidelines and internal company standards, including management of files in an Electronic Document Management System (eDMS) system.He/she works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.The Contract Regulatory Publisher supports adherence to relevant regulatory requirements and company SOPs as appropriate.This is a long term consulting opportunity.Primary duties and responsibilitiesGathers, prepares (as needed) and assembles the essential documents from internal teams and/or external Clinical Research Organizations (CROs) required for US and global regulatory submissions; confirms the accuracy and quality of submission content, obtains required approvals and ensures that the documents are submitted in accordance with external regulatory and internal standards.Publishes electronic submissions in Electronic Common Technical Document (eCTD), or non-eCTD format, for FDA, EMA and other regulatory agencies. This may include source document formatting, internal hyperlinking and bookmarks and sequence level publishing. This may also include interacting with third party publishing vendors to ensure submission timelines are met. The range of submission types includes, but is not limited to, Investigational New Drug applications (INDs)/Clinical Trial Applications (CTAs), Protocol Amendments, Safety Reports, Chemistry, Manufacturing and Control (CMC) Amendments, New Drug Applications (NDAs), Variations, Health Authority Meeting Briefing Packages, Labelling, and Responses to Agency Queries.Creates and facilitates regulatory document- and submission-related eDMS workflows maintaining communication with participating panelists as needed.Monitors progression of workflows providing copies of documentation to colleagues/contractors on request.Maintains and tracks regulatory submission documentation (hard copy or electronic), including regulatory authority correspondence, in an appropriate document management system or hardcopy archive location to ensure regulatory compliance and in accordance with company document standards.May act as a liaison with external, third-party organizations to provide regulatory support for the completion of outsourced regulatory submissions.Minimum level of education and work experienceHigh School diploma and a minimum of 3 years of relevant Regulatory Affairs eCTD publishing experience in a pharmaceutical, biotechnology, CRO or related environment.Special knowledge or skills requiredDemonstrated, hands-on experience preparing regulatory submissions in eCTD format (both US and ex-US).Experience with eCTDXPress electronic publishing software (document and sequence level publishing).Experience with, and the ability to work within, an eDMS structure.Current knowledge of global regulatory standards, registration requirements and approval.Knowledge of European regulatory requirements.Proficiency with use of ISI Toolbox.Understanding of the Quality Assurance (QA) function as it applies to regulatory documents including the ability to review and QC documents intended for regulatory submissions.Proficiency with Microsoft Office.Excellent verbal and written communication skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.Excellent planning, organization and time management skills including the ability to support, manage and prioritize multiple projects.Special knowledge of skills preferredBachelor’s degree in a related discipline.Additional Information

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