Director, Regulatory Strategy EPA

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

ESSENTIAL FUNCTIONS AND BASIC DUTIES

CONTRIBUTIONS

Leadership

• Lead EPA Products Regulatory team in developing and executing regulatory strategies for new product development, business development & licensing opportunities, and post-marketing changes to ensure successful commercialization across product life cycle
• Mentor and guide 2 direct reports

New Product Development

• Provide regulatory strategies with pathway, data, and documentation required by US Federal and State EPAs to register new products and claims
• Represent Regulatory Affairs in cross-functional New Product Development (NPD) teams
• Identify project risks and support development of risk mitigation strategies
• Author, prepare, and submit EPA Federal (FIFRA Section 3) and State Registrations
• Develop and maintain strong relationships with EPA project managers
• Develop and maintain strong, collaborative partnerships with cross functional NPD teams including R&D, Clinical, Quality, Legal, Marketing, Operations and Project Management
• Lead and influence cross-functional teams to ensure technical data and information is accurate, complete and on-time to meet submission timelines
• Review and approve technical documents to ensure completeness, accuracy and compliance with relevant regulations

Current and Emerging Regulation

• Monitor trends, emerging regulations, guidance, and best practices related to product development and compliance
• Identify, interpret, and lead regulatory impact assessments of relevant guidance, regulation, and best practices
• Translate regulatory intelligence and trends into proactive, actionable guidance
• Provide expert advice on regulatory developments and actions
• Represent PDI in trade associations (e.g. HCPA) and regulatory meetings as assigned
• Serve as internal point of contact and internal coordinator for regulatory agencies and external consulting interactions

Compliance

• Lead and/or participate in cross-functional teams to ensure pesticide products meet company policy, procedure, and applicable regulations
• Prepare, submit and maintain Annual State and Federal Pesticide Registrations
• Register, renew, or amend CSFs and product labels with environmental agencies 
• Montor registration status, provide progress updates and communicate timings
• Review/Approve Pesticide labels, claims, and collateral for compliance
• Prepare compliance information (statements and certifications) and respond to customers, government agencies, and third party certification organizations
• Manage adverse event reporting per FIFRA section 6(a)(2) and PRN 98-3 Guidance
• Review change controls to assess impact on EPA registrations
• Maintain complete and accurate EPA Correspondence chronology logs and documentation
• Assist in Agency inspections and audits as needed

Cross-Functional Support

• Collaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Operations, and Quality functions to integrate regulatory requirements into the overall pesticide development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are met
• Problem Solving: Generate hypotheses and investigative strategies to address product development or compliance challenges
• Participate: in State and Federal government inquiries and inspections by preparing meeting materials and response strategies

Operational Excellence

• Maintain and strengthen regulatory documentation, templates, and SOPs to support consistent, high-quality regulatory assessments and strategies
• Partner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projects

Mentorship and Collaboration

• Provide guidance and support to junior regulatory staff and junior cross-functional staff sharing expertise and best practices