Emily Havnewitz
Associate Director of Regulatory Affairs @CSL Vifor
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WORK HISTORY
Associate Director of Regulatory Affairs @CSL Vifor
Winner of a Values in Action Award (Q2 2022) and the overall President’s Award for 2022 for outstanding performance and impact.•Responsible for planning and execution of US regulatory strategy, including document preparation, submission coordination, and clinical trial support.•Provides strategic regulatory guidance aligned with commercialization goals and global development plans.•Drives cross-functional alignment and ensures timely delivery of regulatory milestones across the product lifecycle.•Ensures scientific rigor and compliance through expert application of regulatory science and strategic communication.•Develops submission plans and content for INDs, NDAs, and BLAs (original and supplemental).•Leads FDA interactions and submissions, including ODDs, pediatric plans, Fast Track requests, SPAs, and safety reports.•Authors and coordinates responses to major Health Authority queries and labeling negotiations.•Develops strategic content for briefing packages and formal meeting requests to support regulatory approvals.•Serves as primary US Regulatory contact with FDA, and leads agency meetings and internal preparation sessions.•Conducts regulatory research and competitive intelligence to inform development of regulatory strategy.•Authors regional strategy documents and contributes to labeling strategy, target product profiles, and benefit-risk positioning.•Collaborates with cross-functional partners in clinical, safety, labeling, CMC, and operations.•Leads post-approval regulatory activities, including, pediatric submissions and labeling updates.•Upholds compliance standards and supports audit preparation and execution.•Manages regulatory consultants and provides mentorship and oversight to junior regulatory colleagues.•Maintains RIM systems (LS RIMS, Veeva Vault), including tracking correspondence and regulatory objectives.•Contributes to process improvement initiatives, SOP development, and knowledge-sharing within the department.
EDUCATION
The Johns Hopkins University
Master’s Degree
Northwestern University
Bachelor’s Degree
Westborough High School
High School
ABOUT EMILY HAVNEWITZ
Associate Director of Regulatory Affairs at CSL Vifor
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