Regulatory Affairs Specialist

• Product Registration Liaison to Regulatory Agencies (EPA, States Agencies, NSF, Kosher, Halal, OMRI).
• Liaison to Biocide Primary Registrant and/or Manufacturer Regulatory Departments.
• Provides regulatory know-how and support for biocide application State licensing requirement and processing.
• In collaboration with the Biocide Product Manager, leads all communication pertaining to Biocide registration agreements, label revisions/compliance, amendments, etc. Primary Signatory for master supplemental and/or repack/relabel agreements.
• Review and approve biocide labels. May directly manage and update biocide labels as needed. Manages and oversees label updates to the Federal EPA and State agencies.
• Oversee new Biocide product registrations and renewals. May directly manage and process new product registrations and renewals as needed.
• Analyze new and existing regulations, reviewing documentation, and communicating with regulatory agencies. Staying up to date with new and changing regulations and industry trends.
• Provide regulatory support (including telephone consultation, memos, and letters) to customers and sales staff.
• Construction of letters for customers requesting product FDA (21 CFR) acceptability verification, Confidential Statement of Formulation (CSF), VOC, PFAS and Allergen Statements.
• Manage the updates and approval of EHS1002 - G-C Product Regulatory Approval and Acceptability List.
• Verify that all product-related registrations are current or up to standard. Maintains all product registrations, processes all necessary documents, and updates product registrations resulting from new or revised product formulations.
• Oversee and/or facilitates third-party product-related regulatory audits (i.e., NSF, EPA, Kosher, etc.) conducted at G-C facilities.
• Investigates and writes summary report in response to product-related regulatory audit Corrective/Preventive Action (CAPA) requests.
• Assist sales staff in responding to data requests (product aquatic toxicity testing, calculations of
• In collaboration with the Water Safety Group, provides regulatory know-how and support for supplemental disinfection of potable water.
• Performs/submits annual EPA pesticide (biocides) reporting.
• Collaborate with sales team to report annual pesticide usage for applicators when certain states ask or require this information.
• Create, maintains, and updates product regulatory-related documents and SOPs.
• Collaborate with Product Management Team to fulfill certain regulatory duties.
• Provide other regulatory support as they come up with growing business segments and other tasks as assigned.
• Collaborate with sales team to track and promote the licensing/training of pesticide applicators and maintain a list of applicator licensing requirements for each state.
• Creating Biocide Matrix (list of available biocides available for sale in each state) each month and submitting to Biocide Product Manager to review and approve posting on to Knowledge Base.
• Submit Pesticide Sales Report each quarter for the States requiring report.
• Ensures that Garratt-Callahan maintains proper Pesticide Business licenses with the appropriate states.
• Work extensively with factory and plant personnel to ensure all necessary regulatory compliance and protocols are being achieved in the production, documentation, marketing and shipping of Garratt Callahan products.

• A Science degree in Chemistry, Biochemistry, or Chemical Engineering.

• A good understanding and grasp of the various regulatory requirements/agencies governing the use of water treatment chemicals (EPA, State Agencies, NSF, 21 CFR, OMRI, Kosher, Halal).

• Experience with the regulatory aspects of pest management.

• Knowledge of Google products such as Gmail, Google Docs and Google Meet and proficiency in Microsoft Office Applications such as Microsoft Excel, Microsoft Word and Microsoft Access.

• Computer literate and understand word processing, spreadsheet, presentation, database, and e-mail software sufficient to be proficient with our primary accounting, inventory and manufacturing software.

• The "Equal Employment Opportunity is the Law" poster is available at:
  
• Garratt-Callahan Company's reaffirmation of Equal Employment/Affirmative Action Statement
  

Wünschenswerte Fähigkeiten

• Microsoft Excel
• Microsoft Word
• Microsoft Access

• Burlingame, California

Berufserfahrung

• HR

Sprachkenntnisse

• English