Dessiret Graviel Ortega
Barcelona
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Hardworking and passionate job seeker with strong organizational skills eager to Regulatory Affairs position. Ready to help team achieve company goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
10
10
years of professional experience
Work History
Regulatory Officer
Laboratorios Reig Jofre
04.2023 - 09.2023
- Updating of the table of the products that are manufactured in the SJD factory
- Prioritized project-related tasks to efficiently complete essential tasks.
- Generation and compilation of information with the quality control and quality assurance departments as well as with the suppliers of the active ingredients for the update of the registration dossiers.
- Recommended improvements to processes.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Follow-up with clients in various countries during the registration variation process, providing support throughout the process and responding to allegations received from regulatory authorities.
- Management of ERP software Navision, Lims, Trackwise
Regulatory Affairs
Laboratorios Ferrer
02.2022 - 02.2023
- Preparation, presentation and maintenance of the registration dossier for the active substances of the company
- To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
- Maintained and archived regulatory paperwork.
- Monitoring of dossiers submitted for registration to the relevant authorities in the US, EU and Canada in accordance with the company´s regulatory strategy.
- Management of Opentext, Lims, Trackwise and SAP software.
Pharmacy Assistant
Farmacia Alonso Guerra
06.2021 - 08.2021
- Greeting and answering questions with friendly knowledgeable assistance.
- Keep the pharmacy counter and associated areas clean, tidy and organized.
- Receiving incoming goods and storing them in the right places.
- Verified order information against computer database.
Regulatory Affairs Officer
Laboratorios Lansier
04.2014 - 08.2017
- Preparation of registration dossiers for the registration and variation of pharmaceutical products with health authorities.
- Provide information on the registration dossiers required by the tender, import and marketing areas.
- Recommended improvements to processes.
- Registration submission and follow up with Health Authorities and Licensees, until product approval and launch.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
Quality Assurance Analyst
Drogueria PRODIS
09.2013 - 02.2014
- Review and monitoring of returns
- Oversee the monitoring of change control.
- Related investigations, corrective, preventive and improvement actions.
- Write, maintain and monitor SOPs. Support technical management in the technical management of customers (marketing authorization holders)
Education
Master of Science - Pharmaceutical Sciences
CESIF
BARCELONA10.2022
Master of Science - Pharmacy Technology
CESIF
On Line11.2019
Technician - Microsoft Office 2015
INESEM
GRANADA03.2016
Skills
- Visual Inspection
- Risk Management
- Submission Coordination
- Report Generation
- Regulatory Compliance
- Regulatory Affairs
- Reading Comprehension
- Submission Preparation
Languages
Catalan
Elementary (A2)
English
Advanced (C1)
Timeline
Regulatory Officer
Laboratorios Reig Jofre
04.2023 - 09.2023
Regulatory Affairs
Laboratorios Ferrer
02.2022 - 02.2023
Pharmacy Assistant
Farmacia Alonso Guerra
06.2021 - 08.2021
Regulatory Affairs Officer
Laboratorios Lansier
04.2014 - 08.2017
Quality Assurance Analyst
Drogueria PRODIS
09.2013 - 02.2014
Master of Science - Pharmaceutical Sciences
CESIF
Master of Science - Pharmacy Technology
CESIF
Technician - Microsoft Office 2015
INESEM
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