Experience

Activa-Cro

• Uruguay
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Nov 2021 - Present



PSI CRO AG

• Senior Regulatory Affairs Officer

  • Aug 2020 - Nov 2021

  - liaising with project teams to procure documents necessary for regulatory and ethics committee submissions - preparation and review of regulatory and ethics committee submission dossiers - tracking regulatory project documentation flow and progress reporting - tracking changes/amendments to legislative acts pertaining to clinical trials in PSI countries, and timely notification of all parties involved - creation and maintenance of a database of regulatory requirements - participation in registration/ marketing authorization or renewals - development of regulatory strategies in countries where PSI operational presence is not fully established - communication with ethics committees and regulatory authorities - communication with project teams and customers on all regulatory-related issues - communication with co-contractors, subcontractors, and third-party vendors on the provision of regulatory or related services - acting as a focal communication point for global RA staff regarding corporate practices and procedures - development and update of project planning documents - quality control of regulatory and ethics committee submission dossiers - development and implementation of corporate quality control tools and techniques pertaining to Regulatory Affairs - development of quality systems documents within the functional areareview of investigational product release-enabling documents (IP-REDs) - training company staff in regulatory practices - ensuring accurate and time-bound reporting of safety issues to local authorities - electronic safety reporting to/via EudraVigilance system - mentoring of PSI staff in regulatory-related aspects - participation in feasibility research - assistance with business development tasks Show less



PSI CRO AG

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Officer

  • Dec 2015 - Aug 2020

  Preparation of regulatory/ethics submission dossiers; communication with company staff, clients and vendors and consultation on regulatory/EC submission matters; communication with Regulatory Agencies and Ethics Committees in the country/region assigned, if delegated; Essential study documents/translations review; Maintenance of RA tracking systems; Review of investigational product release-enabling documents (IP-REDs); Compilation and review of Investigational Medicinal Product Dossiers (IMPD), if qualified; Development of project planning documents, if assigned; Development of guidelines and QSDs, if assigned; Safety reporting; Audit participation; Participation in feasibility assessments; Maintenance of regulatory requirements database; Legislation updates: Monitoring and reporting to RA Senior management; Documentation processing; Staff training Show less



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• In-House CRA II

  • Jun 2013 - Dec 2015

  Responsible for Start Up Process in Argentina, Chile, Columbia and Peru. Start Up Process activities include: - Site\Investigator evaluation and recruitment. - Collection, review and maintenance of Essential Documents - ICF customization and review according to ICH-GCP, and local regulations. - Management of clinical site agreements and budget - Management of Import process (license), shipment follow up, customs clearance. Drug shipment Provide regulatory and project specific support to CRAs Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate RSU Specialist

  • May 2012 - Jun 2013

  •Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. •Prepare site regulatory and contractual documents, reviewing for completeness and accuracy. •Inform team members of completion of regulatory and contractual documents for individual sites.•Review, prepare and negotiate site contracts and budgets with sites, as directed .•Distribute completed documents to sites and internal project team members.•Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.•Review, track and follow up the progress, the approval and execution of documents,, including contracts, regulatory and IP Release documents, by coordinating between RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST.•Participate in feasibility and/or site identification activities as required Show less

• Regulatory Affairs Associate

  • Jan 2012 - Jul 2012



PSI CRO AG

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Documentalist

  • Apr 2011 - Jan 2012

  • Primary contact point for project teams for Trial Master File.• Liaison with other company departments.• Review the Trial Master File for completeness.• Ensure compliance with all applicable procedures.• Preparation for participation in internal and third party audits of the local document center.• Perform inspections of the local document center.• Training of company staff in document software and applicable standard operating procedures,• Maintenance of electronic master file.• Supervision and maintenance of the hard copy master file.• Creation of new trial master files at the inception of a new project. Show less

• Document Center Assistant

  • Jun 2008 - Apr 2011

  • Primary contact point for project teams for Trial Master File.• Liaison with other company departments.• Review the Trial Master File for completeness.• Ensure compliance with all applicable procedures.• Preparation for participation in internal and third party audits of the local document center.• Training of company staff in document software and applicable standard operating procedures,• Supervision and maintenance of the hard copy master file.• Creation of new trial master files at the inception of a new project. Show less



Thywill. CRO

• Regulatory Affairs Assistant

  • May 2008 - Feb 2009

  * Liaison between Project Team Members. * Schedule Team events * Organize, archiving, update local study files.. * Prepare documents, binders, printouts (Regulatory & Ethics submissions). * Follow up shipments (correspondence-documents-supplies). * Ensure translation of pertinent documents. * Logistic organization of drug supplies and other supplies shipments. * Assist or perform study Feasibility surveys upon request * Supervision and maintenance of the hard copy master file. * Safety Communication to Local Ecs/IRBs/Regulatory Authorities. Show less



Teletech. Call Center

• Sale Support Desk

  • Mar 2008 - May 2008