Department Name: Research and Regulatory Affairs Location: Mid-Western location Supervisor’s Title: Director, Research and Regulatory Affairs
70k to 100K + perks DOE
POSITION SUMMARY
Under the direction and periodic review of the Director of Research and Regulatory Affairs, the Regulatory Affairs Manager is responsible for the implementation and execution of regulatory functions and strategies to obtain, support, and maintain the international, federal, and state registrations of products in the aquatic and turf and ornamental markets
PRIMARY RESPONSIBILITIES
1. Manage federal registrations with US EPA for new and existing products. In this process, it is important to work with appropriate personnel, including the Director of Research and Regulatory Affairs, to develop and implement the regulatory strategy. This involves completing the necessary submissions and interfacing with regulatory contacts, working with business unit personnel and researchers to develop product labels, and managing regulatory studies to meet data requirements. If required, manages regulatory strategy with the assistance of external regulatory consultants. 2. Maintain existing international registrations and interfaces with international business partners or regulatory consultants as required. Assists in evaluating potential for additional worldwide registrations by working with business partners and other regulatory consultants. 3. Manage the state registration process for products to maintain existing registrations and obtain new state registrations. This includes completing the necessary submissions and communicating with state regulatory contacts and outside business partners. 4. Serve as technical expert on regulatory issues with the business units to address regulatory concerns to support sales of existing products. This includes updates on federal/state registrations, managing information on competitive and potential data compensation issues, and working with local regulators to provide data to support use of existing products. 5. Manage labeling of products by ensuring compliance with EPA and state formatting, and retain archive of all labels. Assist the Supply Chain and Communications teams by providing and working with them to ensure package, specimen, and website labels are consistent with the EPA approved label. 6. Manages Material Safety Data Sheets (MSDS) of products by ensuring compliance with both OSHA and Industry formatting/practice through periodic reviews, and maintain archive file of MSDS. Assists the Supply Chain and Manufacturing team by providing and working with them to ensure MSDS are current. 7. Responsible for the Document Control Center and FIFRA 6(a)(2) reporting. Responsibilities would include filing of regulatory correspondence, documents (state and federal), and maintenance of the document database. For 6(a)(2) reporting, conduct annual employee training, compile information from personnel on potential adverse effects, and submit documentation to EPA and appropriate states. 8. Manage the Registration Review Process for existing active ingredients and placement of regulatory studies that are necessary to satisfy all data requirements. Work appropriately with Study Directors to address issues/needs with regulatory studies. 9. As required, prepares annual regulatory budgets and timelines, and monitors progress throughout the year to provide information to the Director of Research and Regulatory Affairs. 10. Manages data archiving and repository for analytical standards and other materials that are required for regulatory studies. 11. Acts as the primary contact with business partners on regulatory matters.
KNOW-HOW
Technical and Functional Knowledge/Skill Abilities—At a minimum, a Bachelor of Science Degree in a scientific or related discipline. Advanced degrees and five+ years of regulatory experience in the field of Agricultural Pesticides are preferred. Knowledge of the FIFRA regulatory process is required.
Applicant should have good computer skills, including proficiency in excel, word, power point, share point, and other related programs. Personal characteristics of initiative, drive, organization, and attention to detail are important. Candidate should possess excellent verbal, written and listening skills to manage technical issues pertaining to regulatory processes, and have the ability to manage changing priorities and multiple projects at one time. Human Relations—The position requires good communication skills as there is continuous interaction with the marketing/sales, supply chain/shipping, manufacturing, and communications departments. The ability to communicate with federal and state regulatory personnel and maintain excellent professional relationships are equally important. Therefore, good interpersonal skills of both written and oral communication are desired. Additionally, due to the workload required and the relatively small numbers of people involved, the position requires flexibility in thinking and action to accomplish given tasks and goals.
PROBLEM-SOLVING
Natures of thinking—Problems are generally technical in nature. Technical problems are largely non-repetitive and usually urgent and business imperative.
ACCOUNTABILITY
Freedom to Act—Research and Development strategies are agreed upon at the Management Level with input from others within the organization. The work needed to implement these strategies and other R&D responsibilities is carried out with minimal, but routine consultation with supervision. Freedom to set workload and time requirements are permissible with agreed upon permission by supervision, but must meet project goal timeframes. Impact—Results are measurable in meeting timelines and resultant impact on meeting R&D goals and strategies as well as those of the business. The individual has a direct impact on results and an indirect impact on sales and growth of the organization.
