Polly H.
Associate Director, Regulatory Affairs Product Labeling @Boehringer Ingelheim
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WORK HISTORY
Associate Director, Regulatory Affairs Product Labeling @Boehringer Ingelheim
Ridgefield, CT, US
Provides US labeling leadership to help ensure accuracy, consistency, and compliance of Boehringer product labeling with FDA regulation/guidance and Company Core Data Sheet (CCDS)•Leads development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses•Leads labeling cross-functional teams (PLRT), facilitates discussions on labeling content development and strategies for assigned Boehringer products and ensures cross-functional collaboration and alignment (including during labeling negotiations with FDA)•Partners with Global Labeling on CCDS updates and provides assessment/input on US labeling impact•Prepares submission-ready labeling documents (i.e, PLLR Summary, annotated US PI, proposed US PI and associated Patient Labeling)•Supports product launch readiness and launch labeling activities (i.e, expedited availability of product labeling following approval) •Provides US labeling leadership in development labeling activities for oncology assets in support of Real-Time Oncology Review (RTOR) submission pathway•Leads development of target labeling documents to support the design and analysis plan for clinical trials•Authors/reviews labeling sections of periodic reports such as NDA Annual Reports, PDAERs, PBRERs, etc. •Invests time enhancing knowledge of current US labeling regulation/guidance/precedence
EDUCATION
Fairfield University
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Massachusetts College of Pharmacy and Health Sciences
Masters, Health Policy and Regulatory Affairs
ABOUT POLLY H.
Highly driven and motivated regulatory professional with focus on patient centricity. Graduate of Fairfield University, Polly holds a Bachelors of Science in Nursing degree with a business concentration, as well as a Masters in Health Policy and Regulatory Affairs from Massachusetts College of Pharmacy and Health Sciences (MCPHS). A healthcare background with clinical experience enriches her perspective in the industry corporate settings. Polly is dedicated to strategic regulatory approach, especially in the area of US product labeling. Currently, Polly works as an Associate Director of Regulatory Affairs Product Labeling Content at Boehringer Ingelheim. There she is responsible for leading the cross-functional Product Labeling Review Team (PLRT) in drafting/revising product labeling, managing coordination of labeling activities, and compiling documentation for regulatory submissions.
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