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📢 Remote Opportunity | Regulatory Submission Publishing SpecialistThe ideal candidate will support the preparation, publishing, and submission of regulatory dossiers for registration purposes, primarily across US and EU markets.Key ResponsibilitiesCoordinate regulatory submission and publishing activities for US/EU registrationsPrepare submissions in accordance with health authority guidelines and internal proceduresFormat and publish documents according to submission requirementsCollaborate with project leads, regulatory teams, and other stakeholders to collect required documentationTrack submission deliverables, timelines, and deadlinesSupport publication databases and document repositoriesPartner with Regulatory Leads and Managers to ensure submission requirements are fulfilledWhat We’re Looking ForSoft Skills:Strong attention to detail and excellent organizational skillsExcellent written and verbal communicationAbility to manage multiple projects and meet tight deadlinesStrong collaboration skills in a fast-paced environmentTechnical Skills:Microsoft Word & Acrobat ProISI ToolboxVeeva RIMSUS Health Authority portalsGmail, Chat, DMS, and other standard business applicationsFamiliarity with FDA, EMA, ICH, GxP, and publication ethics⭐ Preferred ExperienceExperience within a diagnostics, pharmaceutical, or biotech organization is highly preferred, along with demonstrated experience preparing compliant regulatory submissions.Education: BA in Life Sciences, Regulatory Science, Quality, or a related field — or equivalent professional experience.Experience: 5+ years.Schedule: Flexible days | 24–32 hours/week.
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