Director, Regulatory Strategy EPA

PDI•Woodcliff Lake, NJ

2d•$170,000 - $200,000•Hybrid

About The Position

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 Foster collaborative relationships internally and with external partners/sponsors PERFORMANCE MEASUREMENTS Achievement : Consistent delivery of complete, accurate and on-time high-quality regulatory strategies and project deliverables Ownership : Independent and proactive management of assigned projects to ensure complete, accurate and timely completion Collaboration : Effective teamwork and communication across functions to achieve shared objectives Innovation : Introduction of creative solutions and contributions to process improvements and new product ideas Business Acumen : Effective balancing of compliance risk with commercial goals QUALIFICATIONS EDUCATION/CERTIFICATION BS in life sciences or chemistry

Requirements

BS in life sciences or chemistry
Significant knowledge and working experience in pesticide development, compliance, submissions and Federal and State EPA interactions
Significant knowledge of FIFRA, EPA Guidance, and best practices in pesticidal products development and compliance
Strong scientific understanding of chemistry and toxicology
8 + years of EPA regulatory experience in FIFRA Section 3 Registrations for pesticide products
Demonstrated experience in developing and executing regulatory strategies for new pesticides
Demonstrated experience in obtaining Federal and State EPA Registrations
Federal and State EPA agency interactions
Strong organizational skills with attention to detail, quality, and timelines
Excellent written and verbal communication skills; ability to work in cross-functional teams
Excellent organizational, prioritization abilities, tracking and follow-up skills
Ability to complete projects on time and handle multiple parallel projects in a fast-paced environment
Good analytical and problem-solving abilities, communication and interpersonal, and record keeping skills
Strong attention to detail
Ability to handle multiple tasks / projects simultaneously and bring them to completion on time
Self-starter with ability to think and act independently and to make sound decisions
Fast learner with a flexible style and the ability to adjust to changing business priorities
Ability to interface with internal and external contacts at all levels
Great flexibility and ability to work well with shifting priorities

Nice To Haves

Experience in Pesticidal Devices a plus
MS in Regulatory Affairs a plus
Experience with “Me Too” pesticide regulations a plus

Responsibilities

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
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
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
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
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
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
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
Provide guidance and support to junior regulatory staff and junior cross-functional staff sharing expertise and best practices
Foster collaborative relationships internally and with external partners/sponsors

Benefits

Medical, behavioral & prescription drug coverage
Health Savings Account (HSA)
Dental
Vision
401(k) savings plan with company match and profit sharing
Basic and supplemental Life and AD&D insurance
Flexible Spending Accounts (FSAs)
Short & long-term disability
Employee Assistance Program (EAP)
Health Advocacy Program
Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
sick & safe leave, vacation, company & floating holidays, paid parental leave
summer hours and flex place/flex time options