LiveCareer-Resume

Regulatory Affairs Specialist resume example with 1+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary

Adept at managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. Well-spoken and friendly with top-notch abilities in information verification, report preparation and records management.

Skills
  • Impact Assessment
  • Consumer Inquiry Management
  • Information Verification
  • Technical Guidance
  • Labeling Requirements
  • Product Issue Resolution
  • Training & Development
  • Team Building
  • Data Management
  • Reliable & Trustworthy
  • Computer Skills
  • Critical Thinking
  • Good Work Ethic
  • Microsoft Office
  • Active Listening
  • Problem Resolution
Experience
Regulatory Affairs Specialist, 09/2022 - 04/2023
Agilent Technologies, Inc. Washington, DC,
  • Organized and maintained all files related to regulatory actions.
  • Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Oversaw and coordinated development of annual reports.
  • Updated in-depth trackers of approvals and submissions.
  • Managed regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
  • Produced and filed applications and related documentation for regulatory procedures.
  • Gathered and analyzed scientific data to formulate explanations and arguments for regulatory authorities.
  • Evaluated changes to documents submitted to determine need for amendments.
  • Answered consumer inquiries with friendly and knowledgeable support.
  • Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics.
  • Observed and monitored contracts with outside suppliers to deliver regulatory support.
QA Intern, 06/2021 - 08/2021
Copart Appleton, WI,
  • Assessed daily operations and defined processes to verify compliance with quality standards.
  • Communicated variances to appropriate personnel through detailed reports.
  • Executed or delegated laboratory maintenance and equipment calibrations.
  • Complied with company and regulatory requirements related to safety and quality.
  • Supported variance identification and traceability throughout production processes.
  • Addressed quality issues and worked collaboratively to propose and implement corrective action.
  • Contributed to QC team and project-specific meetings.
  • Evaluated emerging data and trending analyses to inform QC methods and strategy.
  • Coordinated or oversaw scheduled quality audits.
  • Identified quality problems and recommended solutions.
  • Analyzed issues and recommended corrective actions to improve final results.
  • Performed visual inspections of finished products.
  • Conducted tests on product samples and recorded results.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.
Quality Assurance Intern, 01/2021 - 05/2021
Agri Beef Co. Nyssa, OR,
  • Worked with team members to promote great customer service and pleasant work environment.
  • Attended and participated in meetings and brainstorming sessions with team members.
  • Supported various program activities, assisting with administrative tasks.
  • Checked functional requirements by assisting with QA test planning.
  • Gained well-rounded view of managing phases of QA projects from test development to launch.
  • Addressed quality issues and worked collaboratively to propose and implement corrective action.
  • Executed or delegated laboratory maintenance and equipment calibrations.
  • Evaluated emerging data and trending analyses to inform QC methods and strategy.
  • Coordinated or oversaw scheduled quality audits.
Pharmacovigilance Specialist, 02/2020 - 12/2020
Grifols Inc. Rockford, IL,
  • Recorded patient vital signs for medical review.
  • Monitored and coordinated daily patient care activities and supervised medical reviews, health screenings.
  • Evaluated and assessed patients by reviewing medical history.
  • Analyzed issues and recommended corrective actions to improve final results.
  • Performed visual inspections of finished products.
  • Conducted tests on product samples and recorded results.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.
  • Received and inspected raw materials.
  • Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
  • Trained employees in proper equipment use and product testing procedures.
  • Maintained lab cleanliness and safety standards.
Education and Training
Master of Science: Regulatory Affairs , Expected in 12/2023
-
Northeastern University - Boston, MA
GPA:
Bachelor of Science: Pharmacy, Expected in 05/2020
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Charusat University - Changa, Gujarat ,
GPA:

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Resume Overview

School Attended

  • Northeastern University
  • Charusat University

Job Titles Held:

  • Regulatory Affairs Specialist
  • QA Intern
  • Quality Assurance Intern
  • Pharmacovigilance Specialist

Degrees

  • Master of Science
  • Bachelor of Science

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