Tiago Martins
Geneva
Summary
Dynamic Regulatory Affairs expert with over 8 years of experience in the pharmaceutical and MedTech sectors, supporting global health initiatives in Europe, LATAM, and Africa. Skilled in regulatory strategy, lifecycle management, and compliance for diverse product portfolios. Recognized for strong intercultural communication, analytical mindset, and the ability to navigate evolving regulatory landscapes. Committed to enabling successful submissions, improving efficiency, and working with cross-functional teams to support compliance across the product lifecycle.
Overview
2026
2026
years of professional experience
Work History
Regulatory Affairs Specialist
OM Pharma
Geneva
2025 - Current
- Accelerated LATAM submission timelines by conducting comprehensive regulatory gap assessments and ensuring on-time delivery of Marketing Authorizations and lifecycle submissions.
- Strengthened regional execution by serving as the primary point of contact for local regulatory partners, improving alignment and responsiveness across markets.
Regulatory Affairs Specialist (CAS Thesis project)
SaisiR – Science for Rehabilitation
Geneva
2025 - 2025
- Developed regulatory roadmaps for Class IIa medical devices (SaMD), aligning global strategy with local legislative requirements to reduce approval timelines (CE Marking and FDA 510(k)).
Compliance Scientist
CSL Behring
Bern
2024 - 2025
- Strengthened inspection readiness by reviewing 50+ R&D operational training packages (SOPs, WIs, and related documentation), and resolving 15+ compliance gaps ahead of internal and external audits.
- Improved CAPA closure efficiency by 20% by consolidating monthly compliance data and enabling timely corrective actions across cross-functional stakeholders.
Health Product Management (HPM) Specialist
The Global Fund
Geneva
2023 - 2024
- Led the transition from an offline Excel-based tool to an integrated digital platform, coordinating business and IT stakeholders to improve data accuracy and operational efficiency.
RA Process Implementation Manager
Novartis
Basel
2022 - 2023
- Standardized global RA workflows by deploying harmonized SOPs across regional hubs, reducing process redundancy by ~15%.
- Trained 30+ RA professionals on new digital submission tools and global compliance standards, ensuring smooth adoption of updated systems.
Senior Pharmacovigilance Specialist
ProPharma Group
Geneva
2021 - 2022
- Delivered PV training and quality oversight of ICSR case processing to support a major vaccine launch.
- Maintained full regulatory reporting compliance for post‑marketing safety data using Argus and MedDRA.
Regulatory Affairs & Compliance Manager
Shalina Healthcare
Luanda
2018 - 2020
- Expanded market presence in Angola by registering over 10 new products within strict Health Authority timelines.
- Established first localized Quality Management System to ensure supplier qualification met WHO and international standards.
Education
CAS in Clinical, Regulatory & Quality Affairs - Medical Devices & IVDs
HEIG-VD
Switzerland01-2025
Postgraduate Certificate in Health Technology Assessment -
University of Glasgow
UK01-2021
Bachelor in Pharmaceutical Sciences -
Instituto Egas Moniz
Portugal01-2003
Skills
- Regulatory Strategy & Market Access
- Market Authorization & Lifecycle Management
- Regulatory Intelligence & Gap Assessment
- Health Authority & Partner Interaction
- Labeling & Artwork Compliance
- Cross-functional Collaboration (PV, Quality, CMC, Supply)
- Digital Readiness & Regulatory Operations (RegOps)
Technical Skills
Veeva Vault (RIM), Argus, MedDRA, TrackWise, Microsoft suite.
Languages
Portuguese
Native
Native
English
Proficient (C2)
C2
Spanish
Proficient (C2)
C2
French
Upper Intermediate (B2)
B2
German
Elementary (A2)
A2
Timeline
Regulatory Affairs Specialist
OM Pharma
2025 - Current
Regulatory Affairs Specialist (CAS Thesis project)
SaisiR – Science for Rehabilitation
2025 - 2025
Compliance Scientist
CSL Behring
2024 - 2025
Health Product Management (HPM) Specialist
The Global Fund
2023 - 2024
RA Process Implementation Manager
Novartis
2022 - 2023
Senior Pharmacovigilance Specialist
ProPharma Group
2021 - 2022
Regulatory Affairs & Compliance Manager
Shalina Healthcare
2018 - 2020
CAS in Clinical, Regulatory & Quality Affairs - Medical Devices & IVDs
HEIG-VD
Postgraduate Certificate in Health Technology Assessment -
University of Glasgow
Bachelor in Pharmaceutical Sciences -
Instituto Egas Moniz