Melissa Chimenti

About Melissa Chimenti

I have a proven track record of orchestrating seamless regulatory strategies and driving successful product approvals in the pharmaceutical industry. Adept at leading cross-functional teams, I ensure compliance with global regulations while optimizing operational efficiency. I am recognized for strategic insight, innovative problem-solving, and exceptional leadership in navigating complex regulatory landscapes.I specialize in Regulatory Information Optimization, leveraging my expertise to enhance processes and streamline operations within the pharmaceutical industry. My focus lies in maximizing the utilization of Veeva RIMS, prioritizing eCTD submissions, and facilitating effective communication with health authorities. Through my efforts, I\'ve successfully optimized document management processes, resulting in improved efficiency and enhanced regulatory operations.I specialize in driving high-impact process improvement initiatives within the pharmaceutical industry. Recently, I led the successful conversion of all 40 NDA/IND/BLA submissions to the new US Module 1 format, surpassing expectations by completing the milestone a remarkable 4 months ahead of schedule. This achievement significantly streamlined our regulatory submission processes, enhancing efficiency and compliance.In addition, my expertise extends to high-performance team leadership. Through mentoring and guidance, I empowered a managerial subordinate to independently manage regulatory submissions using the ESG system. My effective leadership fostered growth in confidence and skill development, resulting in my subordinate\'s promotion twice within a short timeframe.Key achievements-Spearheaded the revitalization and repurposing of Veeva RIMS as an archival system following the sale of commercial products-Improved the efficiency of upfront authoring and review processes, accelerating document processing timelines by working with the lab group to propose a system, PleaseReview- Contributed to the internal data privacy project, addressing the impact of changing EU and US regulations on data handling practices.If you are looking for someone who is committed to delivering excellence in regulatory affairs, fostering collaboration, and achieving regulatory milestones that propel organizational success, email me: m••••••••@yahoo.com.Key Skills: Document Management | Electronic Document Management Systems (EDMS)| Regulatory Submissions Tracking Systems | Cross-Functional Collaboration | Inspection Readiness | Compliance Audits

Experience

1. Director of Regulatory Affairs

   CorMedix Therapeutics

   Nov 2025 — Present · US

Education

• The College of Wooster

  Bachelor of Arts - BA, Economics

  1996

• Thunderbird School of Global Management

  MIM, International Business

  1998

Skills

• Clinical Development
• Pharmaceutical Industry
• Fda
• Ctms
• Clinical Trials
• 21 Cfr Part 11
• Pharmaceuticals
• Medical Devices
• Clinical Research
• Drug Development
• Gcp
• Biotechnology
• Cross-Functional Team Leadership
• Regulatory Affairs
• Regulatory Submissions
• Program Management