Regulatory Affairs Associate US Generics Labeling Resume Example Company Name

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
Company Name – City, State

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
Company Name – City, State

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
Company Name – City, State

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
Company Name – 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
Company Name – 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

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

Regulatory Affairs Associate US Generics Labeling Resume Example

Resume Score: 60%

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