Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic
Adriana Gonzalez

Adriana Gonzalez

Miami Gardens,FL

Summary

Proficient in current CFR regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

1
1
year of professional experience

Work History

Regulatory Affairs Specialist

Nutrition Formulators
06.2022 - Current
  • Maintained and archived regulatory paperwork.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Prepared and maintained document inventory for core dossier preparation.
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
  • Consolidated global information relevant to CFR regulations and monitored global submissions and approvals status.
  • Developed or tracked quality metrics.
  • Received, researched and resolved consumer inquiries.
  • Recommended improvements to processes.

Education

English-as-a-Second-Language Education

Universidad De Cienfuegos
Cienfuegos
01.2021

Skills

  • Regulatory Affairs
  • Product Information
  • Law Enforcement
  • Labeling Requirements
  • Raw Materials
  • Alternative Medicine
  • Annual Reports
  • Document Review
  • FDA Compliance
  • Corporate Social Responsibility
  • Time Management
  • Regulatory Documents
  • Microsoft Dynamics

Languages

Spanish
Native or Bilingual

Timeline

Regulatory Affairs Specialist

Nutrition Formulators
06.2022 - Current

English-as-a-Second-Language Education

Universidad De Cienfuegos
Adriana Gonzalez