Regulatory Affairs Labeling Associate Resume Example

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Jessica Claire
, , 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - - -
Professional Summary
  • Regulatory Affair Specialist with 3+ years’ experience in Pharmaceutical
  • Experience in Scientific and Technical skills for Regulatory Affairs,
    Quality Assurance and Compliance.
  • Experience with FDA guidelines, submissions to EMEA and Health
  • Electronic submission in eCTD format and via Electronic Submissions
    Gateway (ESG)
  • Author, review and manage regulatory CMC submissions to US FDA for
    IND and NDAs in accordance with FDA/ICH requirements.
  • Coordinate/prepare annual product review and write annual reports for
    commercial APIs.
  • Experience in providing support and regulatory interpretation of Good
    Manufacturing Process to Operations.
  • Work with cross-functional team and manage the process cross functionally associated with Module 3 creation, review, approval, submission and changes.
  • Provided technical training and document support to internal disciplines and external contractors, and supporting various task force activities related to various submission types including INDs, CTAs, NDAs, and MAAs.
  • Experience in Examining and compilation of Labeling, Advertising and
    Promotional materials with Regulatory Compliance.
  • Represented Regulatory Affairs function on cross-functional and technical sub-teams.
  • Data Gathering
  • Compliance assurance
  • Submission preparation
  • International Regulations
  • Organization and Time management
  • Reading comprehension
  • Written Communication
  • MS Office
Work History
02/2019 to 06/2021
Regulatory Affairs Labeling Associate Baylor College Of Medicine Temple, TX,
  • Define and implement labeling regulatory strategy for all products across development and commercialization.
  • Author, assess, and review the core labeling, labeling dossiers as per USP and FDA guidelines.
  • Author and update proposed labeling in working with cross-functional
    stakeholders like Product, Medical Affairs and Vigilance, Package,
    Engineering, and/or marketing.
  • Manage proofreading activities of labeling artwork and support labeling
    Audit readiness activities.
  • Author, manage and approves the development of package inserts,
    promotion and advertising materials.
  • Prepare labeling in Structured Product Labeling (SPL for XML) format
    using specialized software for FDA submissions.
  • Maintain high quality and the error-free environment with respect to all
    labeling components and documentation.
  • Compile detailed documentation for all labeling internal routing, i.e.,
    Quality Documentation Change Notice (DCN).
  • Maintain electronic labeling files for current/proposed components.
  • Maintain and update databases for a variety of projects.
  • Facilitate Labeling working group meetings for respective products.
  • Assist in developing labeling strategies for multiple products and products being developed across multiple indications with innovative solutions to complex processes driving process improvements.
  • Reviews proposed labeling for compliance with applicable US and
    international regulations.
01/2018 to 02/2019
Regulatory Affairs Associate Adventhealth Paola, KS,
  • Utilized peer-reviewed research, FDA Title 21 CFR XXX/211, 21 CFR 820,
    and ICH regulations to gather information on global regulatory submissions.
  • Conducted literature searches and summaries on company-relevant
    scientific topics and provide cross-functional support to R&D and operations.
  • Author and maintain global regulatory submissions, product listings and
    annual registrations package and assist with regulatory Submissions
  • Authored validation protocols, final reports, routine reports, and regulatory agency communications.
  • Prepare and manage materials for recurring meetings related to regulatory updates and CCDS updates.
  • Created and maintained MS word documents. Added Hyperlinks, images, and tables with different styles and formats.
  • Prepared and submitted post-approval submissions (Annual and Periodic Reports for ANDA, NDA, and supplements using ECTD documentation).
  • Submitted Individual Case Safety Report (ICSR) documents using the
    Safety Reporting Portal (SRP) for Adverse Drug Effect (ADE) reporting.
  • Compiled annual product reviews to evaluate manufacturing performance metrics.
  • Experienced with cGMP and GDP.
  • Managed time efficiently with deadline pressures while maintaining
    attention to detail.
  • Assist with research, analysis, and communication of information related to regulatory pathways for different products.
  • Experience with regulations pertinent to medical devices, biologics, and a combination of products.
  • In charge of all business licenses, certificates, and permits on-site. Created and maintain databases to track/maintain all licenses and certificates.
  • FDA 510K submissions and approval for OTC medical devices.
  • Provides support in assessing changes and determining potential regulatory affairs impact on class 11 devices.
  • Assist in 510k submission (Conditional Approval) work in risk assessment.
  • Help in UDI initiatives as well as in global labeling traceability requirements.
  • Worked on registration sections such as: getting legal documents dossier preparations such as technical sections, Labeling.
  • Prepared and compiled the files necessary for the submission activities.
  • FDA 510K submission for machine reader professional use.
  • International medical device registrations for Canada (Health Canada),
    Singapore (HAS), Malaysia(MDA), Korea(KFDA), Mexico(COFEPRIS), Vietnam, Israel, Nicaragua, Egypt, Turkey, Taiwan(TFDA), Russian, and China(CFDA).
  • Renewals and amendments for all the active licenses.
  • Completed various quality-related regulations and documentations. Such as CAPA, machine validations, trending for complains and nonconformance, supplier evaluations, external standards, notary for documents and certifications, FDA and ISO 13485 inspections.
  • Maintain ongoing communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines; ensure that study materials and drug kits are shipped and resupplied as requested; respond to questions related to study protocol independently or refer to others as appropriate; document all conversations in the database.
01/2015 to 02/2017
Pharmacy Technician CVS Specialty Pharmacy City, STATE,
  • Calculated dosage, filled prescriptions and prepared prescription labels with absolute accuracy.
  • Communicated directly with doctors offices via telephone, fax, and email.
  • Entered and processed patients' prescriptions into internal system.
  • Helped pharmacist clear problematic prescriptions and address customer questions to keep pharmacy efficient.
  • Communicated with prescribers to verify medication dosages, refill authorizations and patient information.
  • Works on special projects and assumes functional responsibility for project completion.
Expected in 2007
University of Karachi - Karachi, Pakistan,

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Resume Overview

School Attended
  • University of Karachi
Job Titles Held:
  • Regulatory Affairs Labeling Associate
  • Regulatory Affairs Associate
  • Pharmacy Technician
  • BBA