Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
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Roberta F Wagner

Regulatory and Technical Affairs Specialist
Frankford,DE

Summary

Seasoned regulatory affairs professional is looking for a challenging new role. Proficient in food safety and labeling regulations, standards and best practices. Analytical and detail-oriented focused on making sure products meet all relevant domestic and international regulatory requirements. Good judgment and sound critical thinking and problem-solving abilities. Outstanding communication and presentation skills. Offering more than 30 years' experience.

Overview

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Over 30 years of regulatory and technical affairs experience

Work History

Vice President, Regulatory and Technical Affairs

Consumer Brands Association
Arlington, VA
12.2019 - Current
  • Advocated and spearheaded initiatives with Congress, federal and state regulatory bodies, and NGOs to facilitate CPG industry innovation and growth.
  • Led efforts to enhance CPG product transparency to allow consumers to make more informed purchasing decisions.
  • Identified food safety and regulatory issues and worked with the regulatory community to implement successful solutions.
  • Interpreted proposed regulations and draft industry guidance documents and prepared industry comments for government consideration to assure policies are practical and achievable.
  • Managed a team of five regulatory and technical affairs specialists. Established performance goals for department and outlined processes for achievement.
  • Routinely performed interviews with media as a public face of the company and led the issuance of a weekly regulatory affairs newsletter.
  • Collaborated with senior management to develop strategic initiatives and long and short term goals.
  • Monitored CPG industry trends, keeping current on latest changes and competition in industry.

Assistant Administrator, Office of Policy

USDA Food Safety Inspection Service (FSIS)
Washington , DC
03.2017 - 11.2019
  • Member of federal government's Senior Executive Service (SES).
  • As part of the senior management team, developed annual strategic priorities, tactics, and key performance indicators, communicated these, and tied them to employee performance plans.
  • Led the development and implementation of all domestic and international policy for the organization through 130 staff members.
  • Formulated and executed an office budget of over 1 million dollars.
  • Participated in robust stakeholder engagement through listening sessions, roundtables, public meetings. and one on one discussions to inform policy.
  • Established workflow processes, monitored daily productivity and implemented modifications to improve overall performance of personnel.
  • Evaluated all written work products to assure appropriate scientific support and accuracy.
  • Delivered performance reviews, recommending additional training or advancements.
  • Tracked expenses, processed invoices and completed other related accounting tasks.

Deputy Assistant Administrator, Field Operations

USDA FSIS
Washington, DC
01.2016 - 03.2017
  • Member of the federal government's SES.
  • With the Assistant Administrator, formulated and executed a budget of more than 855 million dollars.
  • Provided leadership and direction for a field workforce of over 7800 inspection program personnel located throughout the United States, responsible for ensuring the safety and security of domestically produced and imported meat, poultry and processed egg products; this involved daily inspection at more than 6000 domestic establishments and reinspections of FSIS regulated imported products at over 50 warehouses.
  • Met with managers and inspectuion program personnel routinely to determine needs and develop roadmaps.
  • Monitored performance to assess training needs and areas in need of improvement.
  • Implemented and maintained high standards of quality in all areas.
  • Promoted transparency by engaging with stakeholders on a routine basis.

Associate Commissioner, FSMA Implementation

FDA Center For Food Safety (CFSAN)
College Park, MD
08.2015 - 12.2015
  • Member of the federal government's SES
  • Agency lead for all aspects of Food Safety Modernization Act (FSMA) post final rule implementation, e.g., lead for the development and implementation of education, outreach, technical assistance implementation plans, and inspection and enforcement strategies to gain widespread compliance with FSMA regulations. This required working across the FDA organization to achieve implementation goals.
  • Agency spokesperson on FDA's FSMA implementation efforts and other food safety related topics in myriad of domestic and international venues.
  • Lead for multi-million dollar budget formulation and execution of funds authorized by Congress specifically for FSMA implementation.
  • Center lead for federal-state food safety program integration efforts and specifically served as member of the Partnership for Food Protection Governance Council.
  • Technical Advisor for the National Association of State Department of Agriculture (NASDA) produce safety cooperative agreements and representative on the FDA-NASDA joint advisory committee charged with developing an operational strategy for overseeing compliance with the produce safety rule by farmers.
  • Led agency efforts to create specialized commodity specific inspection teams to promote streamlined business processes and decision making.
  • y related topics in domestic and international venues.

Deputy Director for Regulatory Affairs

FDA CFSAN
College Park, MD
02.2013 - 07.2015
  • Member of the federal government's SES.
  • Provided strategic direction and leadership to 500 technical and regulatory affairs experts. Direct reports included senior leaders responsible for managing employees in the Office of Compliance, Office of Nutritional Labeling and Dietary Supplements, Office of Analytics and Outreach, and the Office of Food Safety. Led and directed efforts by these offices to establish policies through regulations and guidance documents on a myriad of cross cutting food and nutrition issues.
  • Formulated and executed a multi-million dollar budget.
  • Worked closely with the Office of General Council to assure policies were legally sound.
  • As co-lead for the FDA FSMA Implementation Steering Committee directed the development of post final rule implementation strategies, working across the components of FDA's food program. Recognized as the agency expert and spokesperson on FSMA implementation activities.
  • of HHS priority goal which included uccess.

Assistant Commissioner for Field Operations

FDA Office Of Regulatory Affairs
White Oak, MD
07.2011 - 01.2013
  • Member of the federal government's SES.
  • Led and managed a staff of approximately 3800 through six regional food and drug directors; staff were located in Washington DC, 5 regional offices, 20 district offices, 13 regulatory laboratories, and 200 border and resident posts.
  • Assisted in formulating and executing a budget of over 100 million dollars.
  • Directed the work of FDA's inspection force responsible for conducting thousands of domestic and foreign inspections of regulated food and medical products manufacturing facilities, collecting and analyzing thousands of import and domestic product and environmental samples, and making admissibility decisions for over 20 million import line entries.
  • Directed a staff in developing and implementing a robust quality management system for the work performed by FDA's field operations.
  • Coordinated with FDA's product Centers and the Office of General Counsel to conduct administrative and judicial enforcement actions.
  • Directed and led foodborne outbreak response and post response activities for ORA which included serving as the decision maker and spokesperson for when a recall or enforcement action was warranted, clearing press releases and web postings, and on stakeholder calls.
  • Provided leadership and delivered on the import related provisions of FSMA. Assisted with developing, reviewing and clearing proposed FSMA rules for Lab Accreditation and Foreign Supplier Verification; cleared the Interim Rule on Amendments to Records Availability Requirements; reviewed/cleared the Capacity Building Plan for Congress and oversaw the design of the Voluntary Qualified Importer Program.
  • Lead for Federal-State Integration Taskforce that identified, developed and implemented strategies to achieve full partnership with State agencies.

Education

Master of Science - Biochemistry

Bowling Green State University
Bowling Green, OH

Bachelor of Arts - Biology And Environmental Science

Hiram College
Hiram, OH

Skills

  • FDA and USDA-FSIS - Regulations, Policies and Compliance
  • Technical Writing and Presentations
  • Advocacy for the CPG Industry
  • Written and Oral Communications
  • Policy and Procedure Development
  • Management of People and Resources
  • Diverse Stakeholder Engagement
  • Change Management

Affiliations

  • Association of Food and Drug Officials, Industry Partner
  • Alliance to STOP Foodborne Illness, Industry Partner
  • United Egg Producers, Science Advisory Board
  • International Association for Food Protection

Timeline

Vice President, Regulatory and Technical Affairs

Consumer Brands Association
12.2019 - Current

Assistant Administrator, Office of Policy

USDA Food Safety Inspection Service (FSIS)
03.2017 - 11.2019

Deputy Assistant Administrator, Field Operations

USDA FSIS
01.2016 - 03.2017

Associate Commissioner, FSMA Implementation

FDA Center For Food Safety (CFSAN)
08.2015 - 12.2015

Deputy Director for Regulatory Affairs

FDA CFSAN
02.2013 - 07.2015

Assistant Commissioner for Field Operations

FDA Office Of Regulatory Affairs
07.2011 - 01.2013

Master of Science - Biochemistry

Bowling Green State University

Bachelor of Arts - Biology And Environmental Science

Hiram College

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Roberta F WagnerRegulatory and Technical Affairs Specialist