Mafalda Matos Email and Phone Number

Support regulatory activities related to vaccines in all global markets;Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances related to vaccines;Contribute to the preparation and editing of clinical trial and marketing applications; Development of product-specific regulatory strategy documents; Technical review and approval of master protocols, reports and other source documents;

Preparation of Module 2.3 and Module 3 of in-house developed products.Analysing and collecting source documentation.Audit dossiers.Participating in the requirements definition and product development planning.Developement of document management system for CTD.

Writing CMC parts of regulatory variations for EU and International countries.Writing Module 2 of regulatory files derived from completed CTD Modules 3.Writing Responses to Questions raised by Regulatory Authorities on CMC matters.Update of internal tracking system linked to their CMC activities.Involvement in internal initiatives for improvement of processes/ ways of working.Part of Quality Control SME team.Leader of initiative to develop Module 2… Show more Writing CMC parts of regulatory variations for EU and International countries.Writing Module 2 of regulatory files derived from completed CTD Modules 3.Writing Responses to Questions raised by Regulatory Authorities on CMC matters.Update of internal tracking system linked to their CMC activities.Involvement in internal initiatives for improvement of processes/ ways of working.Part of Quality Control SME team.Leader of initiative to develop Module 2 templates.Internal rotation GRA Clinical Department. Show less

Consultant at GSK Biologicals (Wavre, Belgium)CMC Excellence, Functional Unit 1Writing CMC parts of regulatory variations.Writing Module 2 of regulatory files derived from completed eCTD Modules 3Writing Responses to Questions raised by Regulatory Authorities on CMC mattersUpdate of internal tracking system linked to their CMC activitiesInvolvement in internal initiatives for improvement of processes/ ways of working

Review, edit and proofread regulatory documentations;Compile regulatory documents for submission;Compile and prepare responses to regulatory authorities' questions;Maintain regulatory files in a format consistent with requirements;

Support in variations and new submissions to SwissMedic.Support to MENA countries.Support in packaging compliance.

Dispensing prescriptions and OTC's medicinesCounseling and advising the patientsPharmaceutical CarePreparation of MedicinesPrescriptions Review

Pharmaceutical CarePreparation of MedicinesPrescriptions Review

Preparation and Dispense of medicinesPrescriptions ValidationClinical Pharmacy

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