Adaptable regulatory affairs labeling associate accustomed to the integration of new FDA regulations/guidance and restructuring of work in an increasingly complex regulatory environment.
Regulatory Affairs Associate US Generics Labeling01/2016
to Current Teva Pharmaceuticals USA, Inc. – Woodcliff Lake,
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 Teva Pharmaceuticals USA, Inc – Woodcliff Lake,
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.
to 06/2014 Glamorous Cosmetics – Ridgewood,
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 – Woodcliff Lake,
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.
to 04/2012 Englewood Hospital and Medical Center – Englewood,
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.
Microsoft Office (Word, PowerPoint, Excel, SharePoint)
i4i A4L 5.4 (SPL production)
InSight for Viewing
TVT (Text Verification Tool)
In-depth knowledge of FDA regulations and guidance
Bachelor of Arts: BiologyJanuary 2012Rutgers, The State University of New Jersey-
Associate of Science: A.S. NSM. Bio Associate Science, Natural Science, Math and Biology Science, Math and BiologyMay 2009Bergen Community College-
New Jersey Phi Theta Kappa International Honors Society