Assoc Dir, Regulatory Strategist, Safety & Toxicology

PDI•Woodcliff Lake, NJ

41d•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! POSITION PURPOSE 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.

Requirements

Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus
Solid knowledge of FDA safety regulations; experience with ex-US authorities (Health Canada) desirable
Demonstrated ability to contribute to safety strategies and regulatory submissions across multiple phases of development
8-10 years of safety experience in pharmaceuticals, biotech, medical devices, or pesticides including submission experience in IND/NDA, 510(k), FIFRA §3 or equivalent
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

Responsibilities

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. Non-Animal Tested Declaration, Food Allergen Declaration, "Free from" Declaration
Provide support for compliance requirements (e.g. Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Safety Substantiation, IFRA 52nd Amendment (2026), Hazard Communication Standard (SDS) Updates; California CFFIRKA allergen reporting requirements)
Collaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Manufacturing, and Quality functions to integrate safety findings/plans into the overall drug 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 any safety concerns or unexpected findings that arise during the non-clinical phase.
Participate: in health authority interactions (FDA, Health Canada) by contributing to meeting materials and supporting response strategies.
Maintain and strengthen safety documentation, templates, and SOPs to support consistent, high-quality safety 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 where applicable, 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, and depending on the position we also offer summer hours and flex place/flex time options.