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
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
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
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
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
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
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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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