Portugal
The core of my professional experience is in Regulatory Affairs from both the governmental and Pharma Industry perspectives. I worked at INFARMED, I.P. (National Authority for medicinal products in Portugal) as procedure manager for new marketing authorizations applications, renewals and variations by mutual recognition and decentralised procedures with Portugal as reference member state. I have also the opportunity to develop skills in Pharmacoeconomis and Market Access areas, also at INFARMED, I.P. Since 2016 I am RA Manager at Novartis Portugal, taking responsability over portfolio across several therapeutic areas, and building regulatory expertise from Pharma Company perspective. Between March 2023-March 2025 was in an ad interim position with RA team at Novartis Romania, as OPM in replacement of RA Head, allowing me to develop leadership and people skills in practice. I am further expanding my experience in Regulatory Affairs in a global RA team assignment at Novartis, since July 2025.
Rotation as Global Program Regulatory Manager in Immunology disease unit
Regulatory responsability accross portfolio therapeutic areas (2016-2017 Respiratory, 2017-2020 Oncology, since 2021 Radiopharmaceuticals)
In-replacement for RA Head on leave
Health Technology Assessment, Pricing and Reimbursement Department Procedure manager in applications for reimbursement of medicines in the National Healthcare System. Collaboration in the development and implementation of SINATS - National Health Technology Assessment System in Portugal. Support and executive secretariat activities for the National Pharmacy and Therapeutic Committee, responsible for the elaboration of the National Formulary of Medicines. Quality System Manager for the department.
Medicines Evaluation Department Procedure Manager in MR/DC procedures with Portugal as Reference Member State (new marketing authorisation applications, variations and renewal applications) Collaboration in review and publication of documents and topics discussed in the Variation Working Party of the Coordination Group for MR/DC procedures (CMDh) Collaboration in the review of european regulation and guidelines applicable to variations Implementation of the revised Regulation EC 1234/2008 to the national procedure in Portugal Project manager in the development of updated IT tool for submission and management of variations
Temporary replacement of Technical Director; Opportunity to be involved in a wide range of activities in Technical/Logistic, Regulatory and Pharmacovigilance Areas.