Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014]
Core
Subject matter expert supporting BARDA in regulatory operations for medical countermeasures against CBRN threats, pandemics, and emerging infectious diseases.
Role type
Senior regulatory operations specialist (eCTD submissions)
Builds
Compliant electronic Common Technical Document (eCTD) submissions and regulatory dossiers for FDA
Domain
Healthcare and Life Sciences / Regulatory Affairs / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA submission types expertise, eCTD specifications knowledge, ICH guidelines for CTD dossiers, electronic publishing software proficiency, XML document creation, regulatory policy knowledge, project management for submission coordination
Preferred skills
Certifications in regulatory operations, training in publishing software, experience in medicinal chemistry or preclinical development
Technologies
MS Word, Adobe Acrobat, PDF toolsets, ISI Toolbox, Lorenz
Responsibilities
Design, review, and archive eCTD submissions including original filings and amendments; Liaise with Regulatory Affairs Project Managers and CROs to coordinate submission timelines; Provide expert assessments and guidance on regulatory documents and study protocols; Manage and submit electronic dossiers to regulatory authorities; Support Program Coordination Teams with technical proposals and budget proposals.
Seniority
Senior, hands-on IC
