Senior Director Global Labeling Lead

1 day ago

Cork, Cork, Ireland beBeeGlobalLabelingInitiative Full time €106,362 - €134,451

Lead a Global Labeling Initiative

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  • Develop and execute global labeling strategies to facilitate simultaneous submissions.">
  • Implement initiatives related to global labeling strategy to accelerate reach and scale.">
  • Represent global labeling for assigned products to drug development teams and regulatory business partners.">
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Core Labeling Development and Maintenance

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  • Lead the development and maintenance of core labeling, including Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content.">
  • Prepare activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).">
  • Communicate initial and revised core labeling to global affiliates and provide support and consultation.">
  • Develop and maintain clinical trial Instructions for Use.">
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Labeling Process Excellence

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  • Optimize core labeling exception process and manage core labeling exception requests.">
  • Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.">
  • Resolve identified gaps and issues in labeling processes and drive continuous improvement.">
  • Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.">
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Required Skills and Qualifications

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  • Bachelor's degree in a scientific or health sciences discipline or equivalent experience.">
  • Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.">
  • Demonstrated knowledge of the drug development process and regulatory/business strategies.">
  • Ability to assess and manage risk in a highly regulatory environment.">
  • Effective teamwork skills, adaptability, attention to detail, organizational skills, and ability to learn new software/technology.">
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