Ravit (Rory) Maggen Email & Phone Number

Congerss, Ny

Leading the company’s PMO, overseeing the development, submission, and commercialization of 50+ concurrent NDAs/ANDAs. Support and guide the quality, production, analytical, and regulatory teams in ensuring conformity with FDA and environmental regulations and standardizing operational procedures.• Successfully resurrected hundreds of transferred NDAs/ANDAs, bringing them from post-clinical stages to commercialization.• Developed project plans, change controls, and SOPs.• Devised and implemented risk management strategies, reducing project risk by close to 30%.• Continuously oversaw the operation of cross-functional teams in meeting shifting production priorities and schedules to meet dynamic market demands.

New Haven, Ct

Manage and critically review regulatory submissions for the Clinical Trials Office, overseeing a team of Regulatory and Research Assistants in the preparation of all regulatory documentations at different regulatory milestones. • Organize and drive preparations for FDA inspections and sponsor audits• Conduct employee training programs on regulatory requirements and SOPPs • Prepare and review sections of regulatory submissions for IND and compassionate use, annual reports, and amendments

New Haven, Ct, Us

Supported the activation of new clinical studies, representing regulatory affair in team meetings. Prepared and processed regulatory documents (new submissions, amendments, annual reviews, SAE documents, and IND Safety Reports) for submission to Yale ancillary committees and Institutional Review Board (IRB). Acted as primary regulatory liaison with external CROs to provide support for trial initiation and ongoing maintenance needs.

Rehovot, Israel

Developed, reviewed and approved control documents (SOPs, WIs, Analytical Methods, Batch Records, Protocols, Reports, etc.) for this leading BioPharma company, specializing in Monoclonal antibody biosimilars. • Reviewed equipment and instrument validation, writing URS, DQ, IQ, OQ and PQ protocols and final reports. Developed risk assessment pertaining to the quality, safety and efficacy documentation• Reviewed technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines and requirements

Jerusalem, Israel

Oversaw R&D and production cGMP and cGCP compliance at Dexcel, an international drug developer and manufacturer with products (innovative prescription, generics, and OTC) subject to EMA and FDA regulations.• Reviewed and approved protocols of clinical trials and clinical drug supply labeling. Compiled, reviewed and approved ANDAs, change controls, Supplements and Annual Product Reviews, including lot review and release• Participated in product quality reviews and performed internal audits • Provided quality review of CMC sections of Regulatory submissions

Rehovot, Israel

Participated in the development of pilot projects designed to offer advanced membrane-based separation solutions for the pharmaceutical industry.

Israel

First Lieutenant; headed a Processing Systems Department in an elite Electronic Intelligence unit, commanded over 15 soldiers in three separate teams.

Bachelor Of Science (Bsc), Chemical Engineering

M.Sc., Technology Management