Inês Barradas Mouquinho

I like to be challenged and be part of dynamic teams. I believe that is the best way to grow individually is by working and growing as a team. I have a great desire to learn and discover solutions to the issues that arise in day-to-day work.

Grupo Medinfar - Regulatory Affairs TechnicianRegulatory Affairs Technician

Full-time - Dec 2020 - Present 

- Dossier preparation to register new MAs of Medicines for Human Use in an international context.

- Research, collection and organization of technical, scientific and administrative documentation

- MAs maintenance: notification/submission of variations, extension and/or renewal of MA (MUH)

- Technical and scientifical research to meet the requirements from international Competent Authorities within the established deadlines.

Recipharm - Regulatory Affairs & Pharmacovigilance

Full-time - Mar 2019 - Nov 2020

- MA management: variations, renewals, transfers, etc.

- Contact with Health Authorities

- Pharmacovigilance support on adverse reactions/effects, bibliographic research and analysis of ICSR’s from EudraVigilance.

- Regulatory support on marketing activies such as revision of promotional materials in a regulatory point; notification of advertising material and transparency.

- Reimbursements submission and periodics prices revision- MA management: variations, renewals, transfers, etc. - Contact with Health Authorities - Pharmacovigilance support on adverse reactions/effects, bibliographic research and analysis of ICSR’s from EudraVigilance. - Regulatory support on marketing activies such as revision of promotional materials in a regulatory point; notification of advertising material and transparency. - Reimbursements submission and periodics prices revision

Pfizer - Regulatory Affairs Officer

Full-time - Jan 2018 - Dec 2018

- Identification, implementation and managing key RA Department projects based on both short and long term department objectives.

- Actively contribution to the effetiveness and effiency of RA Department processes, including interactions with HUBs (Labeling, Submission and CMC).

- Responsible for system data updates

- Work for cross-functional project teams, to address business needs in line with business objectives and strategic imperatives.

- Managing projects as necessary to ensure compliance with regulatory authority and corporate requirements.- Identification, implementation and managing key RA Department projects based on both short and long term department objectives. 

Pfizer - Marketing Trainee

Internship - Jun 2017 - Dec 2017 

- Presence in training sessions aligned with the objectives for the development of technical and personal skills

- Organization, review and evaluation of content of materials created taking into account the needs of local clients (like physicians and pharmacists)

- Partnership with the MCC Team in restructuring the health professionals website and selection/inclusion of new content

- Interaction with international teams and clients through various communication channels (eg websites, webinars, email marketing, call center, chat, newsletters, product microsites, remote detailing)

- Use of available databases to monitor the impact of activities and contents in order to maximize impact and customer satisfaction. 

ANF - Associação Nacional das Farmácias - Junior Information Manager at CEDIME

Internship - Sep 2016 - Jun 2017

Achievements: scientific information management from international sources and databases, assign grades according to severity of pharmacotherapeutic interactions, ability to condense information in brief descriptions to support health professionals in clinical practice, store data in Excel sheets and validate them using Excel tools.

Egas Moniz School of Health & Science

Master of Science - MS, Pharmaceutical Sciences

2010 - 2016

Technical-scientific knowledge of Pharmaceutical Sciences

Eurotrials Centre for Clinical Research Training

Regulatory Affairs Course

2017 - 2017

Regulatory procedures in Europe; MA and post-MA procedures; Publicity and transparency; Pharmacovigilance of Regulatory Affairs; Prices and reimbursements; Medical devices.

Faculdade de Direito da Universidade de Lisboa

Pós-Graduação em Direito e Economia da Saúde e do Medicamento

Feb 2022 - Jul 2022

Ethicals of Scientific Research; Health Economics and Pharmacoeconomy Principles; Health Regulation; Patents and International law; Medicies: safety, MAH procedures; Off-Label; European System Evaluation; Pricing and Access; Management of the data;Ethicals of Scientific Research; Health Economics and Pharmacoeconomy Principles; Health Regulation; Patents and International law; Medicies: safety, MAH procedures; Off-Label; European System Evaluation; Pricing and Access; Management of the data;