LiveCareer-Resume

regulatory analyst resume example with 20+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Summary

Hardworking and dedicated Regulatory Affairs Analyst successful at preparing and documenting regulatory paperwork. Tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Attentive and exacting with demonstrated success in handling domestic and international regulatory needs for diverse products. Bringing 20 years of Cosmetic experience and seeking a growth-oriented position.

Skills
  • Consumer Inquiry Management
  • Information Verification
  • Technical Guidance
  • Product Issue Resolution
  • Critical Thinking
  • Fluent in Spanish
  • Microsoft Office
  • Working Collaboratively
  • Reliable and Trustworthy
  • Friendly, Positive Attitude
  • Organizational Skills
  • Customer Service
  • Team Building
Experience
Regulatory Analyst, 09/2005 to Current
KabafusionSomerset, NJ,
  • Updated in-depth trackers of approvals and submissions.
  • Produced and filed applications and related documentation for LATAM and Japan regulatory procedures.
  • Improved operations by working with team members and customers to find workable solutions.
  • Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
  • Prioritized and organized tasks to efficiently accomplish service goals.
  • Demonstrated self-reliance by meeting and exceeding workflow needs.
  • Demonstrated leadership by making improvements to work processes and helping to train others.
  • Point of contact for internal/external business partners in relation to the application of Certificates of Free Sale (CFS) and Good Manufacturing Practice (GMP) certificates from the cosmetic trade association (PCPC). Support finance with the cross charging to International markets.
  • Obtained and distributed of all required foreign regulatory product registrations dossiers to support assigned affiliate and distributor markets for ELC corporate brands.
  • Authored, edited, reviewed and released of all cosmetic and OTC Ingredient Label listings for existing and new formulations across all (29) ELC brands.
  • Preparation and submission of all cosmetic products that are commercially distributed in the US through the FDA's Voluntary Cosmetic Registration Program.
  • Assist the National Drug Code Administrator in organizing and preparation of OTC drug registration files for electronic submission to the FDA. Register all cosmetic and OTC products with Poison Control on a weekly basis.
  • Review existing and new formulations for global compliance.
  • Worked closely with Global Brand Supply Chain to develop solutions and meet deadlines.
  • Assist with the initiation of Safety Data Sheets into the web based Worldwide Environmental Regulatory Compliance Solutions (WERCS) system.
  • Mentored and provided feedback to Junior Analyst to ensure they meet requirements and deliver the expected value to the business objectives.
Global Data Steward - Formula Control, 11/1993 to 09/2002
Church & Dwight Co IncVictorville, CA,
  • Liaison between all global R&D facilities (New York, Minnesota, China, Japan, France, and Canada) and all global manufacturing facilities (Switzerland, England, Belgium, Canada and US), regarding formula released for in site manufacture as well as third party manufacture.
  • Manage the accuracy of product and formula records in RDS including final product name, shade names and product codes. Assign mass codes as per the chemist’s request.
  • Collect standards/samples to send to QA for pre-production and production batches.
  • Manage a reporting of all global mass Bill Of Material releases with senior staff to ensure timelines, completeness, and accuracy on a weekly basis.
  • Point of contact to assign batch numbers to third party manufactures. Served as a subject matter expert in internal processes / procedures.
Quality Assurance Analyst, 08/1989 to 11/1993
Life FitnessDes Moines, IA,
  • Created and implemented a tracking system file for product component standards to increase turn-around time on the distribution of the first-time release of component standards to domestic manufacturing plants therefore reducing the number of outstanding components by over 100%.
  • Ensure the accuracy of artwork files of each component and fully supported the Road Representatives daily when they visited Third Party Manufactures.
  • Recommended improvements to systems and procedures for increased productivity.
  • Set and achieved product quality objectives while meeting product specifications.
  • Administered internal surveys and analyzed results to decipher operational needs and develop targeted solutions.
  • Maintained quality assurance procedure documentation.
Export Coordinator, 07/1988 to 08/1989
Del LaboratoriesCity, STATE,
  • Tracked and traced air shipments with custom brokers in order to maintain current status information.
  • Demonstrated self-reliance by meeting and exceeding workflow needs.
  • Motivated and encouraged team members to communicate more openly and constructively with each other.
  • Coordinated the shipment of finished products to all International markets.
  • Produced, organized and submitted export paperwork to meet all applicable resolutions.
  • Built and strengthened relationships with trucking companies and airlines to optimize daily operations.
  • Consulted customs brokers to arrange passage of goods through customs.
Education and Training
Bachelor of Science: Organizational Management, Expected in 05/2014
St. Joseph College - Patchogue, NY,
GPA:
  • Completed professional development in Labor Relations / Personnel Management.
Languages
Spanish:
Native/ Bilingual
Negotiated:

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Resume Overview

School Attended

  • St. Joseph College

Job Titles Held:

  • Regulatory Analyst
  • Global Data Steward - Formula Control
  • Quality Assurance Analyst
  • Export Coordinator

Degrees

  • Bachelor of Science

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