COVID-19 Resource Center 1.866.648.2767 Email Us Careers Contact Us About Us Investors News TRHCU R&D Pillar Technology Solutions Regulatory and Medical Sciences Research and Development Pillar Research & Development Pillar Home Precision Pharmacotherapy Research & Development Institute Office of Translational Research and Residency Programs Drug Information Resource Center Postgraduate Pharmacy Residencies Office of Healthcare Analytics Regulatory and Medical Sciences Research Projects Projects by Keyword Publications and Reports Publications by Keyword Michael R. Ujhelyi, PharmD, FCCP Senior Vice President, Regulatory and Medical Affairs TRHC effectively crafts regulatory and medical strategies that lead products through the regulatory clearance/approval process (as well as other global regulatory agencies), successfully launching products and monitoring post-market product performance through surveillance. New product value is maximized by providing early stage strategic input to develop superior and differentiated products that have proven real-world medical and economic value preferred by patients and healthcare providers. At the same time, TRHC applies best-in-class quality management system processes throughout the product development lifecycle that meet ridged international standards. The Regulatory and Medical Science department supports product development and commercialization by applying state of the art technical, quality, and clinical evidence processes that meet or exceed expectations for safety, efficacy, quality, and performance of all regulated products. Specific functions of the department include: Providing scientific, medical, and regulatory expertise and guidance in interpreting government regulations, product performance, unmet medical needs, clinical evidence gaps and internal policies Developing, directing, and leading the timely implementation of regulatory and medical business plans for product releases and updates into U.S. and international markets Delivering optimized regulatory and medical strategies for life-cycle management that sustain medical and economic value Integrating with the quality management system, assuring that the product development lifecycle conforms to local and global regulatory requirements Creating and implementing medical plans using best-in-class medical communication practices that enable the safe and effective use of TRHC’s marketed products Building, maintaining, and managing effective professional peer-peer relationships with external experts, advisors and key opinion leaders through scientific/clinical exchange communicating product value and assessing unmet product needs Directing the assessment and improvement of key business processes to ensure compliance with current and future regulations CONTACT US 1.866.648.2767 info@TRHC.com 228 Strawbridge Drive Moorestown, NJ 08057 CAREERS We are looking for individuals who can grow with our company. We offer a comprehensive benefits package, along with competitive compensation. Learn more today by clicking below. See Openings STAY UPDATED Your Name (required) Your Email (required) ©2021 Tabula Rasa HealthCare™ Legal | Privacy | Contact Us By continuing to browse the site you are agreeing to our use of cookies. I Understand