Raquel Abigaíl Villalta Díaz
Antiguo Cuscatlán,La Libertad
Summary
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
5
5
years of professional experience
Work History
Inspector
National Directorate of Medicines
La Libertad
02.2021 - 10.2022
- Company Overview: Blv. Merliot, La Libertad
- Conducted thorough inspections of pharmaceutical products for quality assurance and compliance with regulatory standards.
- Collaborated with cross-functional teams to resolve discrepancies and improve inspection processes.
- Prepared reports detailing findings of inspections, investigations, and tests.
- Effectively communicated with clients and management to ensure alignment on inspection objectives, requirements, and expectations.
Pharmaceutical Product Registration Analyst
National Directorate of Medicines
La Libertad
10.2022 - 08.2024
- Company Overview: Blv. Merliot, La Libertad
- Analyzed regulatory submissions to ensure compliance with sanitary standards and guidelines.
- Reviewed documentation for completeness, ensuring timely processing of applications.
- Collaborated with cross-functional teams to address inquiries related to product registrations.
- Monitored changes in regulations, advising stakeholders on necessary adjustments to compliance strategies.
- Served as a resourceful point of contact for clients seeking guidance or assistance throughout their interaction with our organization.
- Trained new team members on standard operating procedures, contributing to increased productivity levels.
- Supported senior staff in analyzing complex registration cases, offering valuable insights for resolution strategies.
- Accomplished timely completion of assigned tasks while adhering to strict deadlines and quality standards.
- Recognized for exceptional attention to detail while reviewing and validating registration data, ensuring a high level of accuracy for all processed applications.
- Conducted extensive research on regulatory changes to ensure ongoing compliance with all relevant guidelines.
- Checked records for accuracy and completeness, and corrected errors.
- Composed correspondence to internal and external parties as requested.
Pharmaceutical Product Registration Analyst
Superintendence of Sanitary Regulation
La Libertad (Remote)
09.2024 - Current
- Company Overview: Blv. Merliot, La Libertad
- Analyzed regulatory submissions to ensure compliance with sanitary standards and guidelines.
- Reviewed documentation for completeness, ensuring timely processing of applications.
- Collaborated with cross-functional teams to address inquiries related to product registrations.
- Monitored changes in regulations, advising stakeholders on necessary adjustments to compliance strategies.
- Served as a resourceful point of contact for clients seeking guidance or assistance throughout their interaction with our organization.
- Trained new team members on standard operating procedures, contributing to increased productivity levels.
- Supported senior staff in analyzing complex registration cases, offering valuable insights for resolution strategies.
- Accomplished timely completion of assigned tasks while adhering to strict deadlines and quality standards.
- Recognized for exceptional attention to detail while reviewing and validating registration data, ensuring a high level of accuracy for all processed applications.
- Conducted extensive research on regulatory changes to ensure ongoing compliance with all relevant guidelines.
- Checked records for accuracy and completeness, and corrected errors.
- Composed correspondence to internal and external parties as requested.
Education
Bachelor's Degree in Chemistry And Pharmacy - Chemistry and Pharmacy
Salvadoran University “Alberto Masferrer”
San Salvador, El Salvador12-2022
General baccalaureate - undefined
Bethany Institute
01.2015
Skills
- Native Spanish speaker
- Advanced English proficiency
- Active listening in user meetings
- Pharmaceutical regulatory issue resolution
- Evaluation of national and international guidelines for pharmaceuticals
- Product evaluation expertise
- Efficient time management
- Medication review expertise
- Cosmetic product registration
- Comprehensive reporting of inspections
- Ethics and integrity
- Regulatory compliance
PERSONAL SKILLS
Mother tongue: Spanish
Other language(s): English - Advanced, French - Intermediate
Practical/research experiences
Degree thesis: Formulation and development of a topical solution with garlic extract (Allium sativum)
Training
- Health Regulation of Medical Products, 2024.
- Generic and biosimilar drugs, 2024.
- FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA, 2024.
- Electronic Drug Registration and Listing (eDRLS), 2024.
- Investigation of out-of-specification results, 2024.
- OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice, 2024.
- Course for the implementation and strengthening of the Antimicrobial Optimization Programs PAHO/WHO, 2023.
- Online training on the WHO methodology for monitoring antimicrobial consumption – Cohort, 2023.
- Technovigilance, 2022.
- Specialization program for comprehensive regulation of health products in the Andean community, 2022.
- Vaccine Safety Basics, 2022.
- Good manufacturing practices in cosmetics, 2021.
- Good Manufacturing and Storage Practices (Medical Devices), 2021.
- Advanced Good Manufacturing Practices (GMP) Inspections, 2021.
- TRAINING AUDITORS IN QUALITY SYSTEM ISO 19011:2018, 2021.
Awards
Best grade of the 2020 promotion, Association of Pharmaceutical Laboratories of El Salvador, 2020.
Timeline
Pharmaceutical Product Registration Analyst
Superintendence of Sanitary Regulation
09.2024 - Current
Pharmaceutical Product Registration Analyst
National Directorate of Medicines
10.2022 - 08.2024
Inspector
National Directorate of Medicines
02.2021 - 10.2022
General baccalaureate - undefined
Bethany Institute
Bachelor's Degree in Chemistry And Pharmacy - Chemistry and Pharmacy
Salvadoran University “Alberto Masferrer”