Dahlia A. Walters
Sr Regulatory Project Manager @FDA
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WORK HISTORY
Sr Regulatory Project Manager @FDA
Silver Spring, MD, US
Demonstrate leadership and perseverance to drive innovation by participating in cross cutting quality assessments of new drug regulatory review program; completed secondary labeling reviews for Regulatory Project Managers. Employ balanced, disciplined leadership while concurrently managing an extensive and intensive workload with multiple review divisions. Implemented CDER’s PDUFA Vll multi-year Chemistry, Manufacturing and Controls (CMC), Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products with accelerated clinical development timelines and advancing the implementation of innovative manufacturing technologies, exceeded FY23 performance goals by 20%. Serve as Cross Discipline Project Manager for over 100 Investigational New Drug,(INDs), New Drug Applications (NDAs), and Supplemental New Drug Applications(sNDAs) for the Division of Hematology and Malignancies this includes multiple applications that were granted Breakthrough Therapy Designation, Orphan Designation and Fast-Track Designation. As Senior Project Manager, I lead the multidisciplinary review teams (CMC) in identify review issues and guide relevant analyses and regulatory impact considerations for each issue; exceeded FY 23 performance goals for IND Meetings and New Drug Applications. Met 95 % performance goals for SNDA applications FY23.
EDUCATION
University of Pennsylvania
MS, Management/Organizational Development and Economics
University of Pennsylvania
BA, Political Science
ABOUT DAHLIA A. WALTERS
I am a top performer in leading, establishing and implementing regulatory policies and procedures that impact regulatory submissions. I possess over eighteen years of project management experience and eight years of regulatory expertise working for federal agencies (i.e, The U.S. Food and Drug Administration - FDA). As a Senior Regulatory Business Process Manager (RBPM) for the FDA in the Office of Pharmaceutical Quality (OPQ), I manage over 30 drug applications simultaneously and oversee regulatory activities for assigned projects. I interact with Research, Clinical, Project Management, Review, and other staff contributing to applications regarding content and timelines. I\'m well-informed of FDA regulations and guidances, as well as international regulatory requirements,(e.g, ICH). Due to my regulatory knowledge, I\'ve been invited to serve on numerous regulatory work groups (i.e, Group 505 (b)(2) Clearance Committee and 505 (b)(2) Coordinating Committee).I have been instrumental in providing overall project management, regulatory expertise and regulatory research on new drug approvals, investigational drug products, and pre-to post market applications. I consistently demonstrate the ability to lead projects, boost employee morale and foster stakeholder engagement. I am a proven individual contributor, team member and regulatory leader talented in initiating, managing and revitalizing consultative relationships across projects and drug application reviews. I\'m efficient at developing and implementing project plans, compiling and analyzing data and effectively managing diverse projects. I\'m recognized as an innovative leader with a creative approach to problem solving, critical thinking and proven development in regulatory, federal and pharmaceutical industries.
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