Mafalda Matos Email & Phone Number

Portugal

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;

Portugal

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.

Belgium

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

Belgium

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

Brussels

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;

Geneva E Região, Suíça

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

Lisbon

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

Lisbon

Pharmaceutical CarePreparation of MedicinesPrescriptions Review

Palermo,Sicily, Italy

Preparation and Dispense of medicinesPrescriptions ValidationClinical Pharmacy

Lisbon

Sport, Culture and Well - Being Center

International Pharmaceutical Market Access, Post-Graduation

Activities and Societies: Market Access, HEOR, HTA This course covers all aspects of international market access of pharmaceuticals.

Advanced Course: Ctd Module 3 - Quality Section

Training Course On Ctd Module 3

Compile and submit Module 3 (CTD) of your registration dossier. Ensure that Module 3 (CTD) contains aall data needed. Achieve the quickest.

Training Programme In Pharmaceutical Medicine, Regulatory Affairs

Master'S Degree, Pharmaceutical Sciences

Activities and Societies: Sport, Culture and Well-Being Center