Regulatory Affairs Specialist
Charleston WV, South Charleston, WV, USSchaumburg, IL, Schaumburg, IL, US
30+ days agoRequisition ID: 1080
APPLYTO REGULATORY AFFAIRS SPECIALIST
Clearon is looking for a Regulatory Specialist (entry or senior level) to provide expertise and support the registration and sales of its antimicrobial pesticide products. This position requires the ability to assess compliance requirements and identify opportunities to improve, develop and expand Clearon’s product offering. This role reports to the Director of Regulatory Compliance.
Essential Job Responsibilities
- Undertake regulatory actions at the federal, state and international level for new and current product registrations; primarily U.S. EPA FIFRA and Health Canada PMRA for new and existing product registrations. This includes the preparation and submission of EPA label and CSF notifications, amendments and PRIA registration actions.
- Coordinate Clearon’s international compliance obligations, for example under EU-BPR, REACH, or CBP regulations
- Represent Clearon in industry trade associate groups and communicate relevant information impacting the business
- Support new product development with regulatory input, requirements and feedback within regulatory team and in collaboration with business, legal and technology (R&D) partners. Ability to provide regulatory insights, competitor analysis and recommendations Participation in internal product teams and new product development, collaboration with R&D, etc.
- Maintain all registered biocide portfolio documentation and records, and ensure all registrations are maintained and current.
- Prepare and submit all mandatory reporting, including EPA maintenance fees and ensure pesticide production reporting requirements fulfilled
- Provide regulatory guidance and support to Clearon’s business and customers
- Maintain product-specific documentation, certifications or claims (i.e., NSF) including the maintenance of data required by NSF
- Review, and coordinate responses to and data for EPA Data Call-Ins (DCI). Support DCI response to maintain active products registrations
- Review Re-registration Eligibility Documents (RED)
- Oversight of data development for Clearon for example in toxicology/environmental fate and effects/product chemistry
- Manage all WERCSmart submissions and overall database maintenance
- Monitor emerging issues, develop risk assessments, and communicate possible impacts to the business posed by changing global regulations and chemical control laws.
Education & Job Requirements
- Degree from accredited institution in Chemistry, Biology, Toxicology, or related field
- 6+ Years of Chemical Industry Experience
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents
- Ability to respond to common inquiries from customers, regulatory agencies or business community members
- Ability to effectively present information to top management, public groups, and boards of directors
- Experience in product development, regulatory affairs, product stewardship, trade compliance, or risk management. Experience across multiple areas preferred.
- Experience in working with regulatory agencies or areas of concentration such as: EPA, Health Canada, European Union REACH, Good Manufacturing Practices (GMP), Global Harmonization System (GHS), Classification for Labelling & Packaging (CLP), Hazard Communication, Hazard Analysis & Critical Control Point (HACCP), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Pesticides/Biocides, and/or ISO certifications.
- Must have good interpersonal and written and oral communication skills, and capable of collaborating with the business and other functions to support implementation of global product stewardship strategy, regulatory affairs policies, compliance standards, programs and operating procedures as applicable.
- Demonstrate high attention to detail, take ownership and drive results.
- Proven ability to establish cooperative working relationships with regulators and business stakeholders
- Experience in all stages of project / program management to coordinate and prioritize submissions and timing for changes
- Proactively and continually improves their level of knowledge about global chemical-control regulatory requirements
Charleston WV or Schaumberg, IL (Remote Locations Considered)