Jonathan Andres Vásquez Lopez
Regulatory Affairs
Santiago
Summary
Experienced pharmacist with a strong background in regulatory affairs, leveraging technical knowledge and expertise. Currently serving as a RA Coordinator, excelling in dossier submissions to health authorities and efficient management of import procedures, including coordination with customs and local warehouses. Skilled in quality control to ensure accurate analysis execution by meeting materials and standards. Proficient in pharmacovigilance activities, adeptly preparing RMP, PSUR, and IBD notifications, while promptly notifying health authorities about adverse events related to pharmaceutical products.
Overview
5
5
years of professional experience
7
7
years of post-secondary education
2
2
Languages
Work History
Regulatory Affairs Coordinator
Alembic Pharmaceuticals Spa
10.2022 - Current
- Assisted in the development of strategic approaches for new product introductions, considering relevant regulations at every stage.
- Maintained up-to-date knowledge of relevant regulations and guidelines, ensuring company adherence to requirements.
- Provided expert guidance on complex regulatory issues, supporting informed decision-making within the organization.
- Supported successful product launches by coordinating effective regulatory strategies.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
Quality Assurance Officer
Alembic Pharmaceuticals Spa
11.2023 - Current
- Analyze imported products locally and carry out revalidation's or verifications according to current regulations.
- Manage requirements for the execution of quality control activities.
- Optimize resources through negotiations with local quality control laboratories.
Pharmacovigilance Coordinator
Alembic Pharmaceuticals Limited
10.2022 - Current
- Entered data, generated reports, and produced tracking documents.
- Preparation of RMP (Risk Management Plans), PSUR (Periodic Safety Reports)
- Communication with the company's global pharmacovigilance team.
Quality Assurance and Pharmacovigilance Officer.
Pharmamerica
10.2021 - 11.2022
- In charge of quality control activities, which consisted of carrying out quality control analyses for imported products. At the same time, he carried out pharmacovigilance tasks in accordance with current regulations.
Regulatory Affairs Consultant
SERTURNER Asesorías Farmacéuticas
08.2019 - 10.2022
- Supported successful product launches by meticulously preparing submission dossiers and securing timely approvals from authorities.
Education
Diploma in Senior Strategic Management of Health Organizations -
Universidad Andrés Bello
04.2022 - 09.2022
Diploma in Management of Health Organizations in a Competitive Environment - undefined
Universidad Andrés Bello
09.2021 - 04.2022
Diploma in Designing Successful Competitive Strategies for Health Organizations - undefined
Universidad Andrés Bello
05.2021 - 09.2021
Grado - Pharmacist
Universidad Andrés Bello
01.2009 - 01.2015
Skills
- Communication
- Collaboration
- Problem-Solving
- Task prioritization
- Managing resources
- Self motivation
Timeline
Quality Assurance Officer
Alembic Pharmaceuticals Spa
11.2023 - Current
Regulatory Affairs Coordinator
Alembic Pharmaceuticals Spa
10.2022 - Current
Pharmacovigilance Coordinator
Alembic Pharmaceuticals Limited
10.2022 - Current
Diploma in Senior Strategic Management of Health Organizations -
Universidad Andrés Bello
04.2022 - 09.2022
Quality Assurance and Pharmacovigilance Officer.
Pharmamerica
10.2021 - 11.2022
Diploma in Management of Health Organizations in a Competitive Environment - undefined
Universidad Andrés Bello
09.2021 - 04.2022
Diploma in Designing Successful Competitive Strategies for Health Organizations - undefined
Universidad Andrés Bello
05.2021 - 09.2021
Regulatory Affairs Consultant
SERTURNER Asesorías Farmacéuticas
08.2019 - 10.2022
Grado - Pharmacist
Universidad Andrés Bello
01.2009 - 01.2015
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