Senior Reg Ops Specialist SME | Healthcare and Life Sciences [HHS122027]
Core
Senior Regulatory Operations Subject Matter Expert supporting BARDA's R&D of medical countermeasures for CBRN threats, pandemics, and emerging infectious diseases.
Role type
Senior IC Regulatory Operations Specialist (eCTD & Submission Management)
Builds
Compliant electronic Common Technical Document (eCTD) submissions, CSR publications, and EUA filings for regulatory authorities.
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 mastery, XML document creation, regulatory operational activities, project management for submissions, risk/benefit analysis, technical proposal review
Preferred skills
Medicinal chemistry, preclinical development, clinical operations, quality control, manufacturing scalability, sterile manufacturing, electronic publishing software (Lorenz)
Technologies
MS Word, Adobe Acrobat, PDF toolsets, XML, electronic publishing software
Responsibilities
Design, review, and archive eCTD submissions including amendments and original filings; Liaise with Regulatory Affairs Project Managers and CROs to coordinate submission timelines; Provide expert assessments and guidance on regulatory documents and study protocols; Develop work products such as expert summary reports and technical assessments; Advise federal staff on the probability of success for proposed statements of work.
Seniority
Senior, hands-on IC
