{"schemaVersion":"jobsearcher.job.v1","id":"0cdbef234bd201db0e44af4b","url":"https://jobsearcher.com/jobs/0cdbef234bd201db0e44af4b","canonicalUrl":"https://jobsearcher.com/jobs/0cdbef234bd201db0e44af4b","title":"Global Labelling Strategy","description":"Job Title: The Associate Director, Global Labeling Strategy\nLocation: Remote\nDuration: 12 Months\nJob Description:\nThe Associate Director, Global Labeling Strategy for Early Asset has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.\nDrive the labeling strategy to early development activities to ensure consideration of labeling in claims development programs.\nEnsures that the labeling strategy is aligned with the overall product regulatory, registration, commercial and development strategy.\nDrives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for high or medium complex projects in the Development and Lifecycle Management (LCM) projects\nServes as primary contact for cross-functional Labeling Team Member (CFLT), eg Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally\nContributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books.\nCoordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality\nEnsures effective planning of all cross-functional labeling activities\nReviews country labels to ensure labeling compliance and adequacy to the regulatory strategy.\nTrain and provide guidance for other Global Labeling Leads as needed\nParticipates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals\nIdentifies opportunities to influence regulatory policy and climate with respect to labeling content\nRequired Skills:\nMasters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory Experience o Knowledge of Global Labeling Guidances, Drug Development and Commercialization of prescription medicines o Understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS\nA understanding of pharmaceutical drug development.\nPrevious experience with Health Authorities bodies\nProven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implications\nExperience in developing of Target Product Labeling Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.\nProven ability to understand regulatory implications of product strategy related to labeling development, assessment and management\nDemonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment\nAbility to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making\nExperience in managing high to medium complex projects\nExcellent project management, verbal and written communication skills\nKeen attention to detail and accuracy, coupled with the ability to think strategically\nAbility to assimilate clinical and scientific information and present it in a concise manner, and translate them into labeling content\nAbility to think creatively and good excellent problem-solving skills\nTime management skills\nJob Type: Contract\nBenefits:\nEmployee discount\nLife insurance\nReferral program\nSchedule:\n8 hour shift\nDay shift\nMonday to Friday\nWork Location: Remote","company":"TechSpace Solutions","rawCompany":"techspacesolutions","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-04-12T20:32:16.928Z","occupations":[{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Global Labelling Strategy","description":"Job Title: The Associate Director, Global Labeling Strategy\nLocation: Remote\nDuration: 12 Months\nJob Description:\nThe Associate Director, Global Labeling Strategy for Early Asset has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.\nDrive the labeling strategy to early development activities to ensure consideration of labeling in claims development programs.\nEnsures that the labeling strategy is aligned with the overall product regulatory, registration, commercial and development strategy.\nDrives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for high or medium complex projects in the Development and Lifecycle Management (LCM) projects\nServes as primary contact for cross-functional Labeling Team Member (CFLT), eg Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally\nContributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books.\nCoordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality\nEnsures effective planning of all cross-functional labeling activities\nReviews country labels to ensure labeling compliance and adequacy to the regulatory strategy.\nTrain and provide guidance for other Global Labeling Leads as needed\nParticipates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals\nIdentifies opportunities to influence regulatory policy and climate with respect to labeling content\nRequired Skills:\nMasters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory Experience o Knowledge of Global Labeling Guidances, Drug Development and Commercialization of prescription medicines o Understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS\nA understanding of pharmaceutical drug development.\nPrevious experience with Health Authorities bodies\nProven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implications\nExperience in developing of Target Product Labeling Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.\nProven ability to understand regulatory implications of product strategy related to labeling development, assessment and management\nDemonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment\nAbility to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making\nExperience in managing high to medium complex projects\nExcellent project management, verbal and written communication skills\nKeen attention to detail and accuracy, coupled with the ability to think strategically\nAbility to assimilate clinical and scientific information and present it in a concise manner, and translate them into labeling content\nAbility to think creatively and good excellent problem-solving skills\nTime management skills\nJob Type: Contract\nBenefits:\nEmployee discount\nLife insurance\nReferral program\nSchedule:\n8 hour shift\nDay shift\nMonday to Friday\nWork Location: Remote","datePosted":"2026-04-12T20:32:16.928Z","dateModified":"2026-04-12T20:32:16.928Z","hiringOrganization":{"@type":"Organization","name":"TechSpace Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0cdbef234bd201db0e44af4b"},"url":"https://jobsearcher.com/jobs/0cdbef234bd201db0e44af4b"}}