Lachman Consultants, leader in providing consultation and remediation services to the worldwide pharmaceutical and related industries, is seeking a consultant whose expertise includes FDA’s electronic submissions and submission requirements. Candidates must have proficiency in regulatory submissions from creation through publication for major applications (NDA, ANDA, BLA, DMF, and IND), as well as amendments and supplements. The candidate should be aware of FDA Guidance Documents dealing with eCTD requirements for dossier submission, labeling, clinical and non-clinical studies, Drug Listing and Establishment Registration, SPL Data elements, GDUFA Self-ID and promotional materials.
- Electronic submissions requirements (eCTD, SPL, Portable Document Format specifications, STFs);
- Creation, assembly, compilation and publication of electronic regulatory submissions (NDA, ANDA, BLA, DMF, IND) and amendments and supplements to existing Regulatory applications
- Creation / maintenance of eCTD templates based on FDA Guidance Documents and checklists
- ePADERS (Periodic Adverse Drug Experience Reports) submissions to FDA via FDA Electronic Submissions Gateway (ESG) portal; familiarity with ICSRs and FAERS portal submissions
- Module 4, Module 5 clinical studies submissions in eCTD ensuring compliance with current data standards
- Skilled in ISI Toolbox, Adobe Acrobat DC, Lorenz Validation,
- Experience submitting through FDA’s ESG, CDER Direct, NexGen, FAERS and/or FURLS portals
- Creation and submission of Structured Product Labeling for drug listing, drug establishment registration, Self ID, Labeler Codes, and more
B.S. Life Sciences; 5-years hands-on experience in pharmaceutical industry with FDA-related eCTD submissions.