Regulatory Lead
Prom Biocides, Woonsocket, RI, United States
The Regulatory Lead is responsible for the operational management and delivery of regulatory activities to ensure ongoing compliance of the company’s product portfolio across relevant markets. The role focuses on the preparation, coordination, submission, and maintenance of regulatory dossiers and documentation globally in line with regulatory strategies and priorities defined by the Chief Science & Regulatory Officer (CSRO).
Job Requirements
Essential
Bachelor’s degree in Chemistry, Life Sciences, Environmental Science, or a related scientific discipline. Strong experience in regulatory affairs within the chemical industry, with a proven track record of preparing, defending, and maintaining regulatory dossiers. Strong working knowledge of U.S. EPA regulation (including FIFRA and TSCA). Established professional network within the regulatory community in the USA and Europe. Demonstrated ability to manage complex, multi‑stakeholder regulatory work, exercising judgement and accountability for quality and outcomes. Experience working in an international organisation, collaborating with colleagues and partners across different countries and time zones. Preferred
Master’s degree in Chemistry, Life Sciences, Environmental Science, or a related field. Direct experience in biocides regulatory affairs. Exposure to additional international frameworks and authorities (e.g. EU BPR, PMRA Canada, COFEPRIS Mexico). Network in the regulatory field globally, with exposure to multiple jurisdictions and regulatory authorities. Experience working in a scale‑up or founder‑led business, comfortable navigating evolving processes and priorities. Personal Attributes
Highly organized, with strong follow‑through and a bias toward finishing what is started. Pragmatic and solution‑oriented, able to cut through ambiguity and move work forward. Detail‑focused with strong analytical and problem‑solving skills, particularly in complex regulatory contexts. Confident and influential communicator, able to engage credibly with regulators, consultants, and senior business stakeholders. Resilient and comfortable operating under pressure in a hands‑on, evolving environment. Able to represent the company externally when required, including at industry meetings, congresses, or customer discussions on defined topics. Job Responsibilities
Regulatory Operations & Execution
Take end to end responsibility for the preparation, coordination, and submission of regulatory dossiers, renewals, and variations under applicable frameworks (e.g. EPA, PMRA, COFEPRIS, BPR, REACH), ensuring accuracy, quality, and timeliness. Maintain and update regulatory files and technical documentation. Track submission timelines and regulatory milestones to ensure on‑time delivery. Lead the technical development and coordination of responses to regulatory authority questions and challenges, exercising expert judgement and escalating to the CSRO where alignment, risk, or policy decisions are required. Ensure regulatory databases and documentation systems remain accurate and up to date. Take ownership of developing and maintaining an up to date, well structured internal regulatory database that supports reliable regulatory delivery and audit readiness. Implementation of Regulatory Plans
Own the execution of agreed regulatory plans and priorities, applying expert judgement to shape how work is delivered and ensuring high quality, timely regulatory outcomes. Support regulatory assessments for new and existing products. Coordinate internally with R&D, Commercial, and Operations to collect required technical information. Work with internal/external consultants and agencies to support submissions. Regulatory Monitoring & Internal Communication
Monitor relevant regulatory developments and provide summaries of potential impact. Escalate material regulatory risks or uncertainties to the CSRO. Support internal stakeholders with compliance‑related guidance within defined policies. Governance & Compliance
Ensure regulatory documentation aligns with quality management system requirements. Support audit preparation and provide documentation during inspections. Maintain structured, compliant record keeping practices. Core Accountabilities
Accountability for the quality, completeness, and timeliness of assigned regulatory submissions and regulatory outputs. Ownership of regulatory delivery for defined products, dossiers, or markets, with responsibility for identifying risks, resolving issues, and escalating appropriately. Maintaining a high standard of regulatory compliance and audit readiness within assigned scope. Strategic regulatory positioning, external representation at policy level, and final regulatory accountability remain with the CSRO. Job Benefits
Competitive Salary and discretionary performance‑related bonus. Medical Care Plan (choice of 3 Blue Cross Blue Shield plans). Vision Care Plan (BlueCross Vision). Dental Care Plan (BlueCross Dental). 401(k) Retirement Plan (with company match). Vacation – 15 days per year plus additional 11 paid public holidays.
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Essential
Bachelor’s degree in Chemistry, Life Sciences, Environmental Science, or a related scientific discipline. Strong experience in regulatory affairs within the chemical industry, with a proven track record of preparing, defending, and maintaining regulatory dossiers. Strong working knowledge of U.S. EPA regulation (including FIFRA and TSCA). Established professional network within the regulatory community in the USA and Europe. Demonstrated ability to manage complex, multi‑stakeholder regulatory work, exercising judgement and accountability for quality and outcomes. Experience working in an international organisation, collaborating with colleagues and partners across different countries and time zones. Preferred
Master’s degree in Chemistry, Life Sciences, Environmental Science, or a related field. Direct experience in biocides regulatory affairs. Exposure to additional international frameworks and authorities (e.g. EU BPR, PMRA Canada, COFEPRIS Mexico). Network in the regulatory field globally, with exposure to multiple jurisdictions and regulatory authorities. Experience working in a scale‑up or founder‑led business, comfortable navigating evolving processes and priorities. Personal Attributes
Highly organized, with strong follow‑through and a bias toward finishing what is started. Pragmatic and solution‑oriented, able to cut through ambiguity and move work forward. Detail‑focused with strong analytical and problem‑solving skills, particularly in complex regulatory contexts. Confident and influential communicator, able to engage credibly with regulators, consultants, and senior business stakeholders. Resilient and comfortable operating under pressure in a hands‑on, evolving environment. Able to represent the company externally when required, including at industry meetings, congresses, or customer discussions on defined topics. Job Responsibilities
Regulatory Operations & Execution
Take end to end responsibility for the preparation, coordination, and submission of regulatory dossiers, renewals, and variations under applicable frameworks (e.g. EPA, PMRA, COFEPRIS, BPR, REACH), ensuring accuracy, quality, and timeliness. Maintain and update regulatory files and technical documentation. Track submission timelines and regulatory milestones to ensure on‑time delivery. Lead the technical development and coordination of responses to regulatory authority questions and challenges, exercising expert judgement and escalating to the CSRO where alignment, risk, or policy decisions are required. Ensure regulatory databases and documentation systems remain accurate and up to date. Take ownership of developing and maintaining an up to date, well structured internal regulatory database that supports reliable regulatory delivery and audit readiness. Implementation of Regulatory Plans
Own the execution of agreed regulatory plans and priorities, applying expert judgement to shape how work is delivered and ensuring high quality, timely regulatory outcomes. Support regulatory assessments for new and existing products. Coordinate internally with R&D, Commercial, and Operations to collect required technical information. Work with internal/external consultants and agencies to support submissions. Regulatory Monitoring & Internal Communication
Monitor relevant regulatory developments and provide summaries of potential impact. Escalate material regulatory risks or uncertainties to the CSRO. Support internal stakeholders with compliance‑related guidance within defined policies. Governance & Compliance
Ensure regulatory documentation aligns with quality management system requirements. Support audit preparation and provide documentation during inspections. Maintain structured, compliant record keeping practices. Core Accountabilities
Accountability for the quality, completeness, and timeliness of assigned regulatory submissions and regulatory outputs. Ownership of regulatory delivery for defined products, dossiers, or markets, with responsibility for identifying risks, resolving issues, and escalating appropriately. Maintaining a high standard of regulatory compliance and audit readiness within assigned scope. Strategic regulatory positioning, external representation at policy level, and final regulatory accountability remain with the CSRO. Job Benefits
Competitive Salary and discretionary performance‑related bonus. Medical Care Plan (choice of 3 Blue Cross Blue Shield plans). Vision Care Plan (BlueCross Vision). Dental Care Plan (BlueCross Dental). 401(k) Retirement Plan (with company match). Vacation – 15 days per year plus additional 11 paid public holidays.
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