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SC Johnson - International Regulatory Affairs Manager Resume Example

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Nora Butler
XXXX XX XXXXXXXXXX XXX XXXX XXX , Mt. Pleasant , WI 53406 | (H) XXXXXXXXXXXX | XXXXXXXXXXXXXXXXXXXXXXX
Professional Summary
Accomplished and energetic International Regulatory Affairs Manager with a solid history of achievement in US EPA pesticide regulatory programs. Motivated leader with strong organizational, management, and prioritization abilities. Areas of expertise include global product registration submission, regulatory compliance, and information management.
Skills
  • Administration and Management
  • Complex Problem Solving
  • Regulatory
  • Coordination
  • Time Management
  • Leadership
Experience
International Regulatory Affairs Manager 05/2013 to Present
S.C. Johnson, Inc Racine, WI
  • International Regulatory Affairs Manager with overall accountability for securing new and maintaining existing US and global registrations for all registered consumer household cleaning (Pledge®, Mr. Muscle®, Windex®, Scrubbing Bubbles®, Glade®) and pest control (Raid®, OFF!®, Baygon®, Autan® and All Out®) products for S.C. Johnson & Son, Inc. (SCJ).
  • Manage a team of senior registration specialists responsible for submitting registered products to government authorities in operations of over 70 countries and the US Environmental Protection Agency (EPA). 
  • Provide expert advice regarding regulatory strategy and data requirements of global products per country in cases of a pandemic (e.g., H1N1 and Chikungunya) in accordance with EPA and the Centers for Disease Control.
  • Develop and successfully implement optimal risk management strategies through impact analysis and advise global managers in Europe, Russia, Africa, Canada, South America, and Asia Pacific monthly.
  • Work to ensure export/import matters are addressed immediately regarding the EPA, Federal Insecticide Fungicide and Rodenticide Act (FIFRA) labels.
  • Serve as first-level manager on matters pertaining to day-to-day operation of program.
  • Exercise technical and administrative supervision over staff planning, hiring, monitoring, performance, and budgeting costs for complex projects that drives the business.
  • Conduct individual generals and weekly team meetings to discuss speed of registration, team success drivers, formula changes, Organization for Economic Cooperation and Development (OECD) data requirements, timing, production process, and first arrival dates of products to internal customers (marketing, product supply, new product development, and research and development).
  • Provide summary and analysis of new regulations and developing regulatory trends in the field and consult with senior directors and global managers by way of briefings, presentations, and trainings. 
  • Represent the company via outreach by training international authorities and providing comments to regulatory trade associations (American Chemistry Council (ACC) & Consumer Specialty Products Association (CSPA)).
  • Negotiate differing perspectives with regulatory authorities/stakeholders both on specific projects and on larger areas of policy to achieve results, recommendations, and changes favorable to SCJ.
  • Review marketing materials, ads, label artwork, commercials, articles, coupons, special product packs (club/warehouse), YouTube videos, and website content for false or misleading FIFRA regulated content and is solely responsible for accuracy and consistency for SC Johnson.
  • Provide registration input in Good Laboratory Practice meetings for toxicology, chemistry, and efficacy data as well as Good Manufacturing Practice for new submissions.
Product Manager 07/2011 to 04/2013
US Environmental Protection Agency Arlington, VA
  • Served as Product Manager in EPA's Office of Pesticide Programs (OPP), Antimicrobials Division, responsible for advising agency officials of environmental management pertaining to rulemaking, licensing and regulation of pesticide submissions.
  • Managed a team of regulatory reviewers, signed correspondence and product labels, as Product Manager, developed by regulatory staff, gave notice of approval or denial of submissions.
  • Developed, reviewed and implemented environmental standards, policies, and operating guidance for pesticide products which included the use of antimicrobials, slimicides, industrial biocides, water purifiers, material preservatives, disinfectants, sanitizers, viruicides, turburculicides and sterilants.
  • Recognized as national and international expert on the regulatory and administrative aspects of pesticide registration and tolerance setting including data requirements, submissions, product labeling and data compensation.
  • Processed and signed over 100 submissions per week for new registration, amendment, notification, gold seals, and special local needs.
  • Maintained liaison with key officials of EPA, other agencies (FDA), private industry (ACC & CSPA), and environmental organizations.
  • Responsible for obtaining the scientific support of the Risk Assessment & Science Support Branch and the Product Science Branch to perform the science evaluation necessary to make registration, experimental use permit, and tolerance decisions.
  • Provided consistent policy guidance to contractors and EPA product reviewers who had primary responsibility for managing application submissions to ensure congressional deadlines were promptly met under PRIA.
  • Developed and maintained procedures for handling claims for data compensation and trade secret declarations by data owners/registrants.
  • Was available to testify and/or provide support to Agency attorney in legal proceedings involving trade secret or data support matters.
  • Determined when pre-submission conferences for applications were to be held, determined the regulatory personnel in support.
  • Ensured that clear agency positions were provided to the press via our Field External Affairs Division.
Chemical Review Manager 10/2009 to 07/2011
US Environmental Protection Agency Arlington, VA
  • Served as Chemical Review Manager in EPA, OPP, Antimicrobials Division, managing a variety of antimicrobial chemical related submissions concerning pesticide product applications for registration and reregistration.
  • Experience managing complex scientific and technical projects. Experience in the interpretation of toxicity, human health, and exposure data as it pertains to human health risk assessment.
  • Prepared scheduled summary documents as part of the registration review program which were published in the federal register.  
  • Led communication initiatives with ACC & CSPA pesticide industry, private citizens, and internal customers on regulatory issues, reregistration eligibility document (RED) decisions, data call-in notices, registration review for antimicrobial active ingredients, scientific reviews, and pesticide policy as mandated by FIFRA.
  • Organized work assignments and advised registrants on administrative and legal aspects of pesticide registration submissions, and prepared required letters/correspondence.
  • Provided leadership to peers to work towards completing registration review submissions to meet division goals.
  • Knowledge of science, public policy, and pesticide use practices, and regulatory history.
  • Complied with applicable laws of FQPA, FFDCA and FIFRA, other regulations, and policies within OPP while maintaining the security of Confidential Business Information.
Program Analyst 05/2004 to 10/2009
US Environmental Protection Agency Arlington, VA
  • Worked in the Pesticide Re-Evaluation Division (PRD) of EPA OPP to perform tolerance reassessment on all pesticide submissions. Tolerances are defined as the amount of pesticide that can legally exist in a specific commodity, crop group, or sub group (e.g., asparagus; beans, hay; grain, and cereal; poultry). 
  • Responsible for the review of submissions for existing use of a pesticide when new uses were proposed, modified, or canceled. 
  • Completed 14 proposed and final rules in the federal register (2006 & 2007), exceeding program goals. 
  • Created reports on process improvement and efficiency measures for the reregistration program (e.g., reduction in cost and time per reregistration decision) and periodically updated the Program Assessment Rating Tool (PART). 
  • Reported efficiency measures for the Government Performance Results Act (GPRA) by summarizing data gained through evaluating the processes, functions, and activities of the pesticide reregistration program.
Project Manager 04/2002 to 05/2004
ASRC Federal Beltsville, MD
  • As a contractor, over a two year span, managed 4 contract projects concurrently for EPA and US Patent and Trademark Office (PTO).
  • Developed project plans based on an understanding of the overall program priorities and related efforts of the organization.
  • Prepared issue papers, which explained the application of the supporting technical information, statutory requirements, environmental policies and guidance to the regulation.
  • Managed the EPA OPP Public Docket within the Public Information & Records Integrity Branch for the Information Technology and Resources Management Division. 
  • Supported the Agency's rulemaking activities as announced in the federal register concerning special reviews and reregistration.  Provided customer service for the pesticide industry (ACC & CSPA), major environmental groups (CropLife America), legal community, academicians, foreign entities, and private citizens.
  • Ensured security requirements were complied with by understanding the document releasability codes set forth by FIFRA for trade secrets and confidential business information.  
  • Applied management analysis and evaluation techniques for the US PTO, Search and Information Resources Administration.    
  • Developed recommendations for improvements, technical reports, data analysis to assist program managers in decision-making for patent examiners. 
  • Accumulated data from diverse sources, analyzed functional user needs, identified omissions and errors in requirements, conducted feasibility studies, and recommended optimum approaches for training.
  • Performed information management and program analysis services for EPA's Office of Environmental Information (OEI) Immediate Office of the Assistant Administrator and the Office of Planning, Resources, and Outreach.
  • Developed and implemented a full information management program that identified internal operations and maintenance plans for supporting OEI wide policies.
  • Developed timetables and conducted interest meetings with federal senior management. Distributed materials in support of training and information management awareness to the Assistant Administrator of OEI.
  • Managed information management activities for RED reregistration of sale and distribution for EPA OPP PRD.
  • Worked directly with chemical managers to prepare the RED appendices by providing data support guideline requirements for product chemistry, ecological effects, toxicology, occupational/residential exposure, environmental fate, and residue chemistry chapters.
  • Developed and maintained a tracking information system that monitored the following elements: chemical signature date, post RED status, federal register notice, data call-in dates, public comment period, and status of the administrative record.
  • Created a 33 page records assessment report aimed in identifying inefficiencies and obstacles impacting PRD's information management practices and computer systems, identified shortcomings, and provided recommendations for senior management to ensure regulatory consistencies.
  • Managed budget adherence and financial forecast reports. Conducted performance evaluation and training of employees; managed exempt and non exempt staff at 4 contract sites.
Technical Information Specialist 07/2001 to 04/2002
ASRC Federal Beltsville, MD
  • As a contractor, served as a Technical Information Specialist for EPA's Office of Research Development, National Center for Environmental Assessment, Integrated Risk Information Systems (IRIS) Hotline.
  • Assisted Program Managers in the development of a comprehensive inventory database and EPA program support, which led to promotion as manager for other contract projects.
  • Created and maintained various databases that tracked chemical requests, collection maintenance and retrieval tasks.
  • Maintained smooth processing, sorting, classification and coding of materials for integration into database systems.
Graduate Assistant 09/2000 to 07/2001
American University Washington, DC
  • Provided computer-related assistance to graduate students completing class assignments. 
  • Assisted in the coordination of graduate recruitment through outreach materials, main speaker at weekly information sessions, and created/maintained a records database that tracked inquiries.
Records Aide 05/2000 to 09/2000
Armstrong Data Services Arlington, VA
  • As a summer intern, provided records collection and inventory management support to EPA OPP in cooperation with the Freedom of Information Act requirements.
  • First reviewer of pesticide application submissions for registration, analyzed packages using a checklist for complete thoroughness of application requirements.
  • Prepared acceptance and rejection letters of submissions for product manager signature.
  • Executed screening, cataloging, and retrieval of confidential business information for records center.  Prepared, restored, copied, and surveyed environmental dockets and jackets for completeness.
Graduate Assistant 09/1999 to 05/2000
American University Washington, DC
  • Conducted research for Government Performance and Results Act project.
  • Interviewed senators from the House and Senate.
  • Database management of program information.
  • Provided assistance to faculty members with field research.
  • Recognized for research excellence.
Environmental Justice Assistant 02/1999 to 09/1999
Environmental Careers Organization Washington, NW DC
  • As an intern, provided technical and administrative assistance to EPA's Office of Environmental Justice program for National Environmental Justice Advisory Council (NEJAC) projects.
  • Served as team member on State and Tribal Environmental Justice, Small Grants, and Community & Grassroots Team.
  • Coordinated NEJAC findings and action items, analysis of environmental justice data and performed outreach activities to communicate environmental health hazards.
  • Interacted with federal, state, and local government officials, business and community groups, and public on issues of environmental justice.
  • Analyzed policy documents, presented findings to internal and external environmental managers using oral and written communication skills.
Outreach Assistant 01/1999 to 02/1999
National Council for Science & the Environment Washington, DC
  • Non-paid internship, 30 hours per week.
  • Assisted in outreach activities to educate the importance of science for environmental decision making to academic, business, environmental, federal, state and local government communities. 
  • Participated in information gathering meetings and provided environmental policy formulation assistance on projects. 
  • Attended senate and congressional hearings concerning environmental legislation, and produced corresponding summary materials.
Education
Master of Public Administration: Public Administration - Information Management Systems May 2001 American University - Washington, DC
Bachelor of Science: Public Management - Environmental Science Apr 1999 Florida Agricultural & Mechanical University - Tallahassee, FL
High School Diploma: Jun 1994 McKinley Technical High School - Washington, DC
Affiliations
  • American Chemistry Council (ACC)
  • Consumer Specialty Products Association (CSPA)
Publication
Government Performance and Results Act (GPRA) - Cited for research in a chapter of Managing Performance in American Government Edited by Dall W. Forsythe. Research skills recognized by Walter Broadnax, American University Dean of Public Affairs, in his chapter entitled "Quicker, Better, Cheaper? Managing Performance in American Government."
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Resume Details

This is a real resume for a International Regulatory Affairs Manager in Mt. Pleasant, Wisconsin with experience working for such companies as Sc Johnson, Inc, Us Environmental Protection Agency. This is one of the hundreds of International Regulatory Affairs Manager resumes available on our site for free. Use these resumes as templates to get help creating the best International Regulatory Affairs Manager resume.

Previous Companies:

  • SC Johnson
  • Inc
  • US Environmental Protection Agency

Previous Job Positions:

  • International Regulatory Affairs Manager
  • Product Manager
  • Chemical Review Manager
  • Program Analyst
  • Project Manager

Schools:

  • American University
  • Florida Agricultural & Mechanical University
  • McKinley Technical High School

Level of Education:

  • Master of Public Administration
  • Bachelor of Science
  • High School Diploma

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