Regulatory Affairs Specialist

03 Jan, 2022

Jobs

Regulatory Affairs Specialist

SePRO
Carmel, IN

JOB SUMMARY

Under the direction and periodic review of the Regulatory and Government Affairs Leader, the Regulatory Affairs Specialist is responsible for the implementation and execution of regulatory functions to support the registration of SePRO products. These tasks are important to meet the business needs for the Aquatic, Water Quality, Turf and Ornamental and International Business Units.

· Support supervisor in all aspects of federal and state registrations;

· Help maintain label updates and registration;

· Lead 6(a)(2) activities

· Lead SDS maintenance and updates

· Maintain SePRO website for regulatory

· Conduct regulatory intelligence

PRIMARY RESPONSIBILITIES

Registration support: Support supervisor in all aspects of federal and state registrations (existing and new) and submissions for SePRO Corporation products. This process typically involves:

· Completing and assembling necessary paperwork;

· Interfacing with the appropriate regulatory agency (EPA, CDPR, etc.) contacts (as needed);

· Independently preparing more routine submissions

· Collaborating with consultants (as needed) on the more technical aspects of a registration action;

· Collaborating with business partners on regulatory aspects of a registration action;

· Completing electronic submissions to EPA

· Maintain appropriate files and databases to document such activities.

· Being point of contact with SePRO businesses from the regulatory perspective to meet registration objectives and address regulatory concerns that impact the businesses, such as amending federal and/or state registrations/labels;

Label maintenance: Help manage approved labels & version control for SePRO products:

· Work with manufacturing to track labels approved (state & federal), proofed, printed, and on containers; track timing for updates, label stock and business needs

· Help with label updates. Interact with business units, main registrants, marketing and regulatory to update labels to address needs

· Ensure compliance with the most currently approved label text and with EPA formatting requirements (and occasional state requirements);

· Work with SePRO’s Supply Chain and third party vendors in the creation of all packaging components that bear label text (container, box and specimen labels) to ensure consistency with one another and with the EPA approved word file label; and

FIFRA 6(a)(2): Lead 6(a)(2) activities

· Manage incoming 6(a)(2)s and follow up as needed

· Lead quarterly Adverse Events Reporting Committee (AERC) meetings in review of filed incident reports

· Manage federal and state reporting

· Provide and update training for incoming personnel as well as on a continuing, yearly basis to all SePRO personnel.

SDS management: Manage SDS creation and updates for all SePRO products

· Work with vendor to create and periodically update SDSs

· Review SDSs with manufacturing to ensure accuracy and compliance

· Manage process for SDS improvements (conduct studies; review DOT regulations…)

· Ensure compliance with OSHA, DOT and industry (ANSI) formatting/practice

Manage regulatory website activities

· Keep SePRO website up to date with most current labels and SDSs

· Periodically monitors product advertising, literature, videos, marketing claims and press releases to ensure compliance with FIFRA guidelines

Competitive intelligence

· Tracking competitive product actions

· Help with data compensation claims

A successful candidate should:

· have a master’s degree or higher in a relevant science (preferred); or previous experience

· Previous FIFRA, HAZMAT, OSHA, DOT etc. experience is a plus

· have good communication skills, be highly organized and have a strong attention to detail

· have a good command of the English language, and an ability to do technical writing and critically review studies and documents

· be proficient in using the following: Microsoft Office products (Word, Excel, PowerPoint, Outlook, Access is a plus); Adobe Acrobat; other software

To submit your interest in a career with SePRO Corporation, please submit resume and cover letter to hr@sepro.com

Job posted: 2022-01-03