Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Areli Canizales

Costa Mesa,CA

Summary

Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 1 years' experience in Clinical Research and looking for a challenging new role. Seasoned Regulatory Affairs Officer with 1 years in developing effective processes and executing regulatory affairs initiatives for the clinical industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions. 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. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

4
4
years of professional experience

Work History

Regulatory Associate

Altasciences Clinical Los Angeles, Inc.
01.2021 - Current
  • Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Wrote or updated standard operating procedures, work instructions or policies.
  • Received, researched and resolved consumer inquiries.
  • Developed or tracked quality metrics.
  • Coordinated recall or market withdrawal activities as necessary.
  • Implemented regulatory guidance procedures for Clinical Research.

Administration Clerk

Clinica Medica Familiar
03.2019 - 10.2021
  • Interacted with customers by phone, email or in-person to provide information.
  • Established and maintained standard office procedures to achieve demanding targets.
  • Produced high-quality documents, spreadsheets and presentations for internal and customer-facing needs.
  • Managed efficient processing of more than 400 documents per month in a high-volume environment.
  • Delivered clerical support by handling range of routine and special requirements.
  • Prepared meeting materials and took clear notes to distribute to stakeholders.
  • Typed, formatted and edited professional correspondence.
  • Handled incoming phone calls and answered questions from callers.
  • Checked non-functional office equipment, troubleshot issues and independently resolved concerns to maintain team productivity.

Education

GED -

Orange Coast College
Costa Mesa, CA
05.2018

GED -

Newport Harbor High School
Costa Mesa, CA
07.2016

Skills

  • Data Verification
  • Corporate Social Responsibility
  • International Regulations
  • Active Listening
  • Critical Thinking
  • Investigational New Drug (IND) Processes
  • Registration Coordination
  • FDA Compliance
  • Annual Reports
  • Regulatory Documentation
  • Impact Assessment
  • Quality Assurance
  • Reading Comprehension
  • Corporate Policies
  • Study Coordination
  • Internal Audits
  • USA Patriot Act
  • Drug Activity
  • Regulatory Affairs
  • Time Management

Languages

Spanish
Native or Bilingual

Timeline

Regulatory Associate

Altasciences Clinical Los Angeles, Inc.
01.2021 - Current

Administration Clerk

Clinica Medica Familiar
03.2019 - 10.2021

GED -

Orange Coast College

GED -

Newport Harbor High School
Areli Canizales