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Regulatory Affairs Associate US Generics Labeling Resume Example

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REGULATORY AFFAIRS ASSOCIATE US GENERICS LABELING
Professional Summary
Adaptable regulatory affairs labeling associate accustomed to the integration of new FDA regulations/guidance and restructuring of work in an increasingly complex regulatory environment.
Work History
Regulatory Affairs Associate US Generics Labeling01/2016 to Current
Abbott Laboratories – Naples , FL
  • Ensure regulatory compliance, accuracy, timely completion and version control on all new and revised labeling components with minimal guidance.
  • Regularly monitor and assess Reference Listed Drug labeling updates.
  • Prepare pre- and post-approval labeling submission documents including cover letters, 356h forms, annotated comparisons, Structured Product Labeling and content plans.
  • Create new labeling for original application submissions through the assistance of project managers, marketing, device specialists and CMC associates.
  • Work closely with artwork management, packaging sites, and marketing to facilitate labeling implementation.
  • Attend Continuous Process Improvement Team meetings with Artwork Management in efforts to enhance the process of creating final printed labeling from word drafts and PDF mark-ups.
  • Analyze and research historical product information in order to prevent subsequent issues.


Labeling Specialist II07/2014 to 01/2016
Living Spaces Furniture – Rancho Cucamonga , CA
  • Created and prepare labeling supplements and amendments for eCTD and hybrid submissions.
  • Constructed and revised Structured Product Labeling in PLR and non-PLR format.
  • Reviewed product labeling for accuracy, completeness, consistency, and regulatory compliance.
  • Interacted with legal to confirm patent/exclusivity carve-outs based on filing strategy.
  • Specialized in the maintenance of Teva's Women's Health products (oral contraceptives and hormone replacement therapy) labeling components.
  • Effectively prioritized tasks and organized workflow to increase efficiency.



Product Specialist05/2013 to 06/2014
Danbury Health Systems – Carmel , NY
  • Clearly communicated key product features, use and benefits to all team members.
  • Handled busy schedules and stayed on top of key deadlines.
  • Attended promotional events in efforts to answer any product related questions.
  • Educated customers about the brand to incite excitement about the company's mission and values.
  • Planned and coordinated logistics and materials for all company meetings.
  • Researched current industry trends, new application techniques, and packaging for the purpose of product development.

Labeling Technician II04/2012 to 05/2013
Teva Pharmaceuticals USA, Inc – City , STATE
  • Managed and prepared labeling amendments and supplements for FDA regulatory submissions.
  • Created and proofread all inserts, patient information inserts and container labels to ensure FDA compliance.
  • Interacted effectively with different departments in order to coordinate and facilitate documentation required for submissions.
  • Maintained a database of the current labeling components.


Pharmacy Technician01/2008 to 04/2012
Englewood Hospital And Medical Center – City , STATE
  • Processed and dispensed prescriptions in assistance to pharmacists.
  • Assisted pharmacists in answering drug information questions presented by other healthcare professionals within the hospital.
  • Proficient in aseptic technique.
  • Prepared inpatient intravenous therapy and oral medications.
  • New Jersey Board of Pharmacy Pharmacy Technician License # 28RW0029300.

Skills
  • Microsoft Office (Word, PowerPoint, Excel, SharePoint)
  • Adobe
  • i4i A4L 5.4 (SPL production)
  • InSight for Viewing
  • Global InSight
  • TVT (Text Verification Tool)
  • VeevaVault
  • Lotus Notes
  • Pyxis MedStation
  • In-depth knowledge of FDA regulations and guidance 
Education
Bachelor of Arts: BiologyJanuary 2012Rutgers, The State University of New Jersey- City, State
Associate of Science: A.S. NSM. Bio Associate Science, Natural Science, Math and Biology Science, Math and BiologyMay 2009Bergen Community College- City, State Phi Theta Kappa International Honors Society
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Resume Overview

School Attended

  • Rutgers, The State University of New Jersey
  • Bergen Community College

Job Titles Held:

  • Regulatory Affairs Associate US Generics Labeling
  • Labeling Specialist II
  • Product Specialist
  • Labeling Technician II
  • Pharmacy Technician

Degrees

  • Bachelor of Arts : Biology January 2012
    Associate of Science : A.S. NSM. Bio Associate Science, Natural Science, Math and Biology Science, Math and Biology May 2009

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