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    Caroline Tranié

    Regulatory Operations - eCTD Expert - Submissions to Health Authorities

    Professional Background

    Caroline Tranié is a highly experienced and dedicated Regulatory Operations professional, bringing over 15 years of specialized knowledge in eCTD (electronic Common Technical Document) submissions to various Health Authorities worldwide. Her expertise has positioned her as a significant player in the regulatory landscape, and she has made substantial contributions to the efficiency and effectiveness of global regulatory submission processes. Caroline has successfully managed the allocation of regulatory submission workloads and has been pivotal in harmonizing operations across multiple sites. Her role often involves analyzing trends to identify areas for improvement, ensuring compliance, and driving continuous enhancement within regulatory procedures across global teams. Her extensive experience in this niche field showcases her commitment to advancing regulatory practices and fostering collaboration among stakeholders.

    Education and Achievements

    Caroline Tranié holds a Bachelor of Arts degree in Secondary Education from La Salle University, where she honed critical skills that transcend into her career in Regulatory Operations. The educational foundation provides Caroline with strong communication and organizational skills, essential for working in complex regulatory environments. Throughout her career, she has worked with leading organizations to streamline regulatory submissions and enhance operational excellence.

    Career Journey

    • Global Regulatory Publishing at CSL Behring: Caroline has made significant contributions to CSL Behring, where she works in Global Regulatory Publishing. Her role has allowed her to amplify her skills in crafting, reviewing, and submitting eCTD applications, which demonstrate her deep knowledge in regulatory requirements and submission strategies.

    • Manager, Global Regulatory Operations at Teva Pharmaceuticals: Caroline held the role of Manager of Global Regulatory Operations at Teva Pharmaceuticals before joining CSL Behring. In this capacity, she oversaw the regulatory submissions for diverse projects, demonstrating her capability to lead teams through the complexities of global regulatory landscapes and manage submission timelines effectively.

    • Manager, Worldwide Regulatory Submissions at Wyeth/Pfizer: During her tenure at Wyeth (now part of Pfizer), Caroline was instrumental in orchestrating worldwide regulatory submissions, successfully navigating the intricacies involved in achieving compliance with various health authorities. Her understanding of regulatory frameworks and her meticulous approach ensured successful submissions.

    • Regulatory Affairs Associate at Elan Drug Delivery: Caroline began her career as a Regulatory Affairs Associate at Elan Drug Delivery, where she developed her foundational knowledge of regulatory processes and began applying her skillset in the pharmaceutical industry. This early experience allowed her to cultivate an understanding of the regulatory environment and hone her submission strategies.

    • Quality Assurance at ViroPharma Incorporated: In her role at ViroPharma, Caroline gained critical insights into quality control processes associated with regulatory submissions, enriching her broad understanding of compliance and quality assurance in the industry.

    Notable Achievements

    Throughout her career, Caroline has been known for her ability to foster collaboration across diverse teams, enhance regulatory compliance, and drive initiatives aimed at increasing efficiency in regulatory submission processes. Her efforts in managing workload effectively and harmonizing operational practices have not only optimized submission timelines but also ensured adherence to evolving regulatory standards across the globe. Caroline's proactive approach to continuous improvement places her at the forefront of Regulatory Operations professionals. Her career is marked by her commitment to excellence and a steadfast focus on ensuring that the highest levels of compliance are maintained within her organizations.

    Related Questions

    How did Caroline Tranié develop her expertise in regulatory operations over her 15+ year career?
    What strategies has Caroline Tranié implemented to enhance eCTD submissions at CSL Behring?
    In what ways has Caroline Tranié contributed to the harmonization of regulatory processes across global teams?
    What trends has Caroline Tranié identified in regulatory submissions during her time at Teva Pharmaceuticals?
    How does Caroline Tranié stay current with evolving regulatory standards and best practices?
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    Location

    Greater Philadelphia