Regulatory Process Coordinator

• Aug 2023 - Present

Senior Regulatory Affairs Specialist

• Jun 2021 - Aug 2023

• Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/ countries.• Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.• Knowledge in tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.• Ensuring that IP labels are in adherence to country requirements and submitted where applicable.• Perform role of Local Reviewer in the QC process as appropriate.• Providing consultancy to the client on any country specific issues if requested.• Attending internal and external project team meetings.• Support Business Development opportunities by providing regulatory input.• Contribute to the maintenance and collection of Regulatory Intelligence; communicate new information or changes• Perform quality control of documents provided by sites.• Perform Regulatory, Start-up and maintenance activities in accordance with applicable regulations, SOPs and work instructions.• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.Ensure that the KPIs are being met and propose changes to plans when the dates/documents are not available or do not occur as planned.• Contact sponsors to discuss regulatory strategy and negotiate deadlines.• Coordinate in accordance with local regulatory requirements, all Suspected Serious and Unexpected Adverse Reactions (SUSARS), SUSAR Semi- Annual Reports (SSRs) and Development Security Update Reports (DSURs). Show less

Regulatory Affairs Analyst

• Oct 2018 - Jun 2021

•Prepare site regulatory documents, reviewing for completeness and accuracy.•Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.•Review and provide feedback to management on site performance metrics.•Review, track and follow up the progress, the approval and execution of documents, including regulatory, ethics, ICF and IP Release documents, in line with project timelines.•Perform quality control of documents provided by sites.•Perform Regulatory, Start-up and maintenance activities in accordance with applicable regulations, SOPs and work instructions.•Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure that the KPIs are being met and propose changes to plans when the dates/documents are not available or do not occur as planned.•May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies. •May have direct contact with sponsors on specific initiatives.•May act as Local Regulatory, Ethics Expert and reviewer of ICF.•Preparation of the initial ethical dossier and submission to IRB-IEC and Health Authority.• Submit, in accordance with local regulatory requirements, all Suspected Severe and Unexpected Adverse Reactions (SUSARS) the SUSAR Semiannual Reports (SSRs) and the Development Security Update Reports [DSURs). Show less

Clinical Trials Assistant

• Aug 2017 - Oct 2018

Assistant position at IQVIA working specifically on Roche studies, mainly related to Oncology.The key responsibilities are related to providing clinical, administrative and regulatory support to the CRAs and other team members. A summary of the activities include to prepare, handle, distribute, file, and archive clinical documentation and reports; Perform the review of study files periodically for accuracy and completeness; Participate on site accompanied monitoring visits; Be the central point of contact during the feasibility and start-up, before the allocation of CRAs on the study; Track the submission and approval of relevant documents to IRB; Accurately maintain clinical systems updated according to the studies' timelines and milestones. Show less

Clinical Trials Assistant

• Nov 2015 - Jul 2017

Solve regulatory issues using the Platform Brazil to submit safety information, protocol deviation, partial and final reports, protocol amendment, investigator brochure, informed consent form and initial dossier, document maintenance, point of contact between CRO, sponsor and the research center. Solve regulatory issues using the Platform Brazil to submit safety information, protocol deviation, partial and final reports, protocol amendment, investigator brochure, informed consent form and initial dossier, document maintenance, point of contact between CRO, sponsor and the research center.

Pharmacy Assistant

• Nov 2014 - Aug 2015

Dispensing of standardized and prescribed drugs, patient care, organization of patient processes, drug separation, sector organization, medication checking and validity. Dispensing of standardized and prescribed drugs, patient care, organization of patient processes, drug separation, sector organization, medication checking and validity.

Pharmacy Assistant

• Jul 2014 - Nov 2014

Dispensing standardized and prescription drugs, dispensing materials for procedures in nursing care, counting and conference validity of standardized medicines and materials, satellite pharmacies, separation medications. Dispensing standardized and prescription drugs, dispensing materials for procedures in nursing care, counting and conference validity of standardized medicines and materials, satellite pharmacies, separation medications.