Senior Nonclinical Regulatory Strategist & Submission ...

Senior Nonclinical Regulatory Strategist & Submission Author at Cardinal Health in Boise, Idaho, United States Job Description Role Summary The Senior Nonclinical Regulatory Strategist & Submission Author leads the strategy, planning, and authorship of nonclinical components for global regulatory submissions across development and lifecycle management. This role partners closely with cross-functional technical teams and clients to develop fit-for-purpose nonclinical strategies, author CTD Modules 1/2/4, respond to Health Authority (HA) queries, execute dossier conversions to contemporary standards, and drive inspection/audit readiness-ensuring accuracy, compliance, and on-time delivery. Key Responsibilities Responsibilities include, but are not limited to: + Clinical trial applications and amendments. + Authoring nonclinical sections (Modules 1, 2, and 4) of registration dossiers for US, EU, and other regions, including preparing international marketing applications such as IRDs, NDS, BLAs, and JNDAs. + Preparing Annual Reports (IND, NDA, Canada YBPR). + Authoring post-approval Supplements, Variations, Renewals, and compliance assessments. + Using nonclinical templates and source documentation to prepare nonclinical reports for clinical trial applications, registration dossiers, annual reports, and post-approval submissions. + Preparing and updating nonclinical sections of Marketing Applications and Authorizations. + Developing global nonclinical regulatory strategies for product development and post-approval lifecycle management. + Preparing nonclinical sections for US Annual Reports and DSURs, ensuring accuracy and timely delivery. + Preparing responses to Health Authority queries and requests for nonclinical data. + Performing inspection-readiness audits of client or vendor facilities. + Conducting vendor qualification audits and/or study monitoring on behalf of clients. + Maintaining fluency in evolving global nonclinical regulations. + Liaising with clients regarding technical submission details and project strategy development. + Supporting project management and relationship management activities with clients. + Verifying CHRS-prepared nonclinical sections against validated source documentation. + Verifying client-prepared nonclinical sections using validated source documentation provided by the client. + Conducting dossier conversions of older submissions, involving mapping content to CTD structure, correcting formatting, filling data gaps, and preparing scientific justifications. + Verifying formatting, proofreading, transcription accuracy, an To view full details and how to apply, please login or create a Job Seeker account

Created: 2026-02-02