Regulatory Affairs Labeling Operations Specialist

Company DescriptionJoulé has been a trusted partner for over 30 years, providing innovative workforce solutions to leading clinical, scientific, and healthcare organizations. Dedicated to excellence, Joulé supports critical initiatives and major projects within the life sciences sector. With a strong foundation built on character, integrity, and commitment, Joulé operates as a division of System One, helping clients achieve their objectives efficiently and effectively.To be qualified for this role, you MUST have the following:Vast experience in PLR – SRPI – CFR format requirements for branded PI, MG, PPI, IFU, and container labeling.Highly proficient in proofreading prescription pharmaceutical labeling using TVT for text comparison and verification. (Not OTC)Able to rapidly reassess and realign priorities when circumstances change, taking decisive action to keep work moving forward efficiently. Role DescriptionThis full-time, remote based opportunity as a Regulatory Affairs Labeling Operations Specialist. We are We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist (Contractor) to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include reviews across the product family of leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain.Relationships:Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.Key Responsibilities: Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirementsIdentify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolutionMonitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practicesEssential Functions:Label Development: 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 timelinesEnsures additional filing requirements are completed for approved content of labeling to include SPL Drug Listing, FDA 2253s and Puerto Rico RegistrationsLabeling Tools: 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 groupsUtilizing FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with internal groups and external agencies to resolve any issuesRegulatory Support: Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexityCompetence 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 RegistrationsSkills and Experience: 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 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. You will be responsible for supporting regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. You will work closely with cross-functional teams to meet regulatory standards and support product labeling initiatives in adherence to industry standards and applicable laws.