Assoc Dir, Regulatory Strategist, Safety & Toxicology

Assoc Dir, Regulatory Strategist, Safety & Toxicology

Job Category: Directors

Requisition Number: ASSOC
006608

• Posted :
  November 24, 2025
• Full-Time
• On-site

Showing 1 location

Woodcliff Lake, NJ 07677, USA

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!

The Associate Director, Regulatory Affairs Strategy – Safety and Toxicology will develop and execute product safety strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as overseeing raw material and formula clearance for product safety and compliance. The ideal candidate will combine strong regulatory knowledge with hands‑on experience to ensure product safety over the full life cycle of a diverse portfolio of healthcare and consumer regulated products including but not limited to drugs, devices, cosmetics, surface sanitizers and disinfects.

• Lead Product Safety and Toxicology team in developing and executing safety strategies for new product development and maintenance of existing products to ensure successful commercialization across product life cycle
• Develop and execute non-clinical safety strategies to generate pre-clinical data for new product development marketing authorization applications
  • Investigational/New Drug Applications (IND/NDA)
  • Medical Devices Pre-Market Notifications (510(k))
  • Pesticides – FIFRA §3
• Develop and execute non-clinical safety strategies for qualifying impurities and new inactive ingredients
• Assess non-clinical safety data and advise project teams on potential in-vitro and in-vivo clinical and non-clinical safety study requirements
• Design, coordinate and monitor in-vitro and in-vivo clinical and non-clinical safety studies
• Ensure studies comply with Good Laboratory Practice (GLP) standards and FDA and HC recognized regulatory guidelines
• Author and review non-clinical sections of regulatory submission documents (IND/NDA/510(k)/FIFRA §3)
• Prepare, oversee, and deliver raw material and formulation toxicological risk assessments, safety clearances, and Consumer Products Safety Reviews (CPSR)
• Prepare, oversee, and deliver Safety Data Sheets (SDS) for drugs, devices, disinfectants, cosmetics and cleaning products
• Represent Product Safety in cross-functional new product development (NPD) teams
• Represent PDI at industry meetings related to safety (SOT, PCPC, HCPA)
• Monitor trends, emerging regulations, guidance, and best practices (regulatory intelligence) related to safety compliance and product development
• Communicate and collaborate in acting on regulatory intelligence that has potential to impact the business
• Ensure products meet all the necessary Federal and State safety regulations and reporting requirements for U.S. and CA

• Review, approve, and certify all formulation raw ingredients, nonwovens, packaging, and fragrances for intended use, country of launch (U.S./CA), and compliance with latest regulations and customer requirements
• Generate Safety Data Sheets (SDS) by reviewing formulations and developing safety, precautionary, and first aid language
• Ensure supplier compliance by updating Raw Material Information Review (RMIR), nonwoven, packaging, and fragrance requirements according to the latest regulatory and customer requirements
• Obtain third party seals of approval from EPA Safer Choice, EPA Design for Environment (DfE), National Eczema association (NEA), United States Department of Agriculture Biobased (USDA), and Environmental Working Group (EWG)
• Provide support for safety related claims e.g.…