Regulatory Affairs Labeling Operations Specialist

• 3–5+ years of labeling experience
• Labeling development experience
• SPL preparation & submission experience
• Minimum 1 year, including validation error resolution
• Strong technical knowledge of labeling systems, including: TVT (primary system; >50% usage), ALiCE / i4i (iXi Forms), SPL tools, LIFT, Artwork Software
• Manual proofreading experience (>70% of role)
• Familiarity with FDA Patient Labeling Resources and PLR format
• True global labeling experience
  
  
  
  

• Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements
• Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution
• Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices.

• Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
• Ensures additional filing requirements are completed for approved content of labeling to include SPL Drug Listing, FDA 2253s and Puerto Rico Registrations

• Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.) as well as coordinating technical support needs with internal IT groups
• Utilizing FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, View email address on us.fitly.work and coordinating with internal groups and external agencies to resolve any issues

• Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
• Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations

• Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information (SRPI), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations.
• Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel.
• Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices.
• Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.
  
  
  
  
  
  
  
  
  Ref: #568-Clinical

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