for Life Cycle management and Original Dossier DevelopmentEssential duties and responsibilities (included but not limited to the following (Other duties may be assigned):Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) ng electronic publishing tools, and an EDMS system.Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of document‐level publishing and submission readiness of source documents for submission‐level publishing.Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams.Provide expertise on regulatory publishing and authoring activities.Provide support for preparation, submission, tracking, and archival of electronic and paper submissions.Assist with development of assigned regulatory operations work instructions.Perform User Acceptance Testing (UAT) for publishing tools, as required.Participate in new technology evaluation for regulatory publishing needs.Stay abreast with updates for regulatory and/or industry standards.Required CompetenciesOverall knowledge of FDA/EMA/HC/SwissMedic/TGA/MHRA/MedSafe regulations/guidance and industry standards for electronic and paper submissions.2+ years of experience luding formatting, publishing, submitting, lifecycle management, and archiving regulatory submission sequences.Demonstrated ability to manage and deliver time-sensitive regulatory submissions while meeting critical deadlines.2+ years of experience with Document Management Systems (Documentum-based preferred) and regulatory publishing tools, including Lorenz docuBridge, InSight Publisher, Lorenz eValidator, GlobalSubmit Validate, GlobalSubmit Review, and ISI Toolbox.Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.Recent experience with NDAs / MAAs/ NDSs and document level publishing is essential.Benefits:Competitive salaryFlexible remote work optionsComprehensive health insuranceOpportunities for professional development and growthPaid time off and holidaysSupportive and collaborative work environmentJoin our team at Freyr Colombia SAS and make a significant impact in the world of regulatory submissions!About Freyr Colombia SAS:Freyr Colombia SAS is the largest global Regulatory Solutions & Services provider, supporting large, mid, and small global Life Sciences companies in their entire Regulatory value chain. Our services range from Regulatory Strategy, Intelligence, Dossiers, Submissions, to Post-Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.Our Specialties:Include Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Global Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, and more.With over 1,370 global clients and a presence in over 22 countries, Freyr leverages its expertise to provide comprehensive regulatory support, including intelligence-driven submissions, product registrations, labeling, artwork, post-approval change management, and regulatory software.
8 days ago