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Regulatory Strategist (New Drug Application)

Company: ARM Life Sciences
Location: Trenton
Posted on: October 21, 2019

Job Description:

Advanced Resource Managers are looking for a Regulatory Strategist (New Drug Application) to support our client on a 6 month project with scope to extend to 10-12 months. The successful candidate can be based in New Jersey, New York or Boston and will be working on a fully remote basis with some occasional travel. -- Please review the following details of the role - -- Key responsibilities --- -- -- -- -- -- -- End to End NDA submission activity (i.e. initial submission, NDA acceptance, and review to approval stage) --- -- -- -- -- -- -- Expert in regulatory operation and strategic support for NDA --- -- -- -- -- -- -- Expert in technical content review of dossier before submission of NDA --- -- -- -- -- -- -- Gap analysis for the original NDA dossier (M1 to M5) before submission --- -- -- -- -- -- -- Review of the response drafted by client is required for agency query post NDA submission --- -- -- -- -- -- -- Therapeutic category of the drug is endocrine and metabolism and/or cardiovascular and renal --- -- -- -- -- -- -- Work closely with development team to improve overall strategy across all departments. -- Experience and Skills --- -- -- -- -- -- -- 10 years + experience working in a regulated, life science environment with strong project management interpersonal skills --- -- -- -- -- -- -- Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting --- -- -- -- -- -- -- Extensive knowledge of Global submission standards (FDA, HC, EMA, ICH eCTD etc), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDA) and Regulatory Operations --- -- -- -- -- -- -- Advanced working knowledge of eCTD Publishing systems, ISI Toolbox and related tools -- If you are interested in this role please email your cv and covering letter to

Keywords: ARM Life Sciences, Levittown , Regulatory Strategist (New Drug Application), Other , Trenton, Pennsylvania

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