Juan Camilo Enciso Beltrán
Barcelona,No se han definido teléfonos.
Summary
A Regulatory Affairs, Business oriented professional, with extensive expertise in the pharmaceutical regulatory field.
Excellent Project Management skills, capable of delivering key communications with clarity, impact and passion.Ability to lead and offer creative solutions to regulatory problems, while balancing the expectations of Health Authorities.Ability to Recognise potential long term issues for projects..
Overview
8
8
years of professional experience
Work history
Regulatory Affairs Officer
Boehringer Ingelheim
San Cugat del Vallès , Barcelona,Spain
2023.01 - Current
-Collaborated with local and global stakeholders to submit and successfully register new medicinal products, as well as maintain existing marketing authorisations and notifications, in line with local requirements and global standards. Ensure timely and compliant regulatory submissions.
-Coordinated of different activities and responsibilities in order to perform various regulatory processes (Clinical Trial Application and amendments, packaging and labelling, and Supply Chain issues).
Business Development Manager
Geiser Pharma
Pamplona , Navarra, Spain
2022.02 - 2023.01
-Secured new business opportunities by cultivating strong relationships with potential clients.
-Developed strategic partnerships for sustained growth.
-Performed new regulatory strategies to reach new business opportunities.
CMC Regulatory and Quality Officer
Bayer
Alcalá de Henares, Madrid, Spain
2021.09 - 2022.02
- Maintained updated dossiers for the products commercialized in more than 80
countries.
-Reviewed regulatory and quality documentation for CMC department,
- Performed change control work packages for CMC changes.
Regulatory Affairs Officer
Geiser Pharma
Pamplona, Navarra, Spain
2018.06 - 2022.02
-Conducted DCP, MRP, RUP, and National procedures in almost all member states within the EU for more than 50 international companies from the pharmaceutical sector.tical
sector.
-Conducted national procedures in non-European countries, with experience in the management of CPPs, GMPs for third countries, and certificates for the supply of products manufactured in the EU, legalisations, and apostilles.
-Interacted with different health authorities within the EU and non-EU countries.
Quality Assurance Officer
Fresenius Kabi
Bogota, Colombia
2016.09 - 2017.02
- Carried out training sessions in GMP, GDP, GSP.
-Performed customer service support regarding quality complaints.
Education
Master of Business Administration - MBA
EAE Business School
Barcelona, Spain 2024.06 -
Foundations of Management Specialization - Management
IESE Business School - University of Navarra
Barcelona, Spain 2022.05 - 2022.10
Master of Science - Research, Development and Drug Innovation
Universidad de Navarra
Pamplona, Spain 2017.09 - 2018.12
Bachelor of Pharmacy -
Universidad Nacional de Colombia
Bogotá, Colombia 2011.06 - 2016.08
Skills
-Regulatory compliance
-Drug development knowledge
-Packaging and labelling
-Project management
-Cultural awareness
-Efficient multitasking
-Operational leadership
-Strategic planning
Languages
English
Advanced
Spanish
Proficient (C2)
German
Beginner
Affiliations
- taekwondo
- Travelling
Timeline
Master of Business Administration - MBA
EAE Business School
2024.06 -
Regulatory Affairs Officer
Boehringer Ingelheim
2023.01 - Current
Foundations of Management Specialization - Management
IESE Business School - University of Navarra
2022.05 - 2022.10
Business Development Manager
Geiser Pharma
2022.02 - 2023.01
CMC Regulatory and Quality Officer
Bayer
2021.09 - 2022.02
Regulatory Affairs Officer
Geiser Pharma
2018.06 - 2022.02
Master of Science - Research, Development and Drug Innovation
Universidad de Navarra
2017.09 - 2018.12
Quality Assurance Officer
Fresenius Kabi
2016.09 - 2017.02
Bachelor of Pharmacy -
Universidad Nacional de Colombia
2011.06 - 2016.08