João Pinheiro
Lisbon
Summary
29 year-old innate team worker, committed multi-tasker Portuguese Pharmacist looking for challenges. Regulatory Affairs enthusiast with a taste for the development of skills and extra knowledge acquisition that will help me grow into the professional I aim to be.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Specialist
Tecnimede Group
Lisbon
10.2023 - Current
- Preparationion, management and submission of MA applications (human products) in the European Economic Area, under different types of procedures (NPs, DCPs, RUPs) in distinct formats (eCTD, NeeS);
- Managed post-authorisation activities (variations, renewals, withdrawals) for Tecnimede Group and business partners, ensuring compliance and timely submissions;
- Development and monitoring of the post authorisation stage for national procedures and MRP/DCP (EU and non-EU countries).
- Created and revised CMC documentation, facilitating accurate regulatory submissions;
- Preparation, revision and approval of information for SmPC, PIL and Labelling.
- Reviewed and revised artworks, ensuring adherence to regulatory standards and enhancing product compliance.
- Communication and articulation with Logistics, Business Development, Quality Assurance and other relevant areas of Tecnimede Group, Regulatory Agencies and Business partners.
- Experience with EU regulations and guidelines.
Regulatory Affairs Officer
INFARMED, I.P.
Lisbon
05.2021 - 09.2023
- Validated and approved Type IA, IB and II variations and renewals of medicines under national, decentralised, or mutual recognition procedures.
- Reviewed and interpreted European and national guidelines for variations of Medicines Marketing Authorization,
- Facilitated communication and collaboration with relevant departments of INFARMED, I.P. and European Regulatory Agencies,
- Engaged with Marketing Authorization Holders to ensure compliance and facilitate regulatory processes.
- Managed and utilised databases including SMUH-Alter, CTS, and GiMed for regulatory activities.
- Evaluation of local and common product labelling (SmPC, PIL).
Education
Masters - Pharmaceutical Sciences
Faculdade de Farmácia, Universidade de Coimbra
Coimbra01-2019
Skills
- Regulatory compliance
- Problem solving oriented
- Flexibility
- Resilience
- Commitment
- Communication skills
Languages
Portuguese
First Language
English
Advanced
C1
Hobbies and interests
- Cycling, basketball and padel
Timeline
Regulatory Affairs Specialist
Tecnimede Group
10.2023 - Current
Regulatory Affairs Officer
INFARMED, I.P.
05.2021 - 09.2023
Masters - Pharmaceutical Sciences
Faculdade de Farmácia, Universidade de Coimbra