The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Pharmaceuticals, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Electronic Submission Expert
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,
Creation and submission of Structured Product Labeling for drug listing, drug establishment registration, Self ID, Labeler Codes, and more
5-years' hands-on experience in pharmaceutical industry with FDA-related eCTD submissions.
Telecommuting is allowed.
Internal Number: eCTD
About Lachman Consultant Services, Inc.
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries.
With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is
proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of
practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.