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PDI · 3 days ago

Assoc Dir, Regulatory Strategist, Safety & Toxicology

Woodcliff Lake, NJ

Full-time

Hybrid

Director/Executive

$150K/yr - $180K/yr

8+ years exp

PDI is a company committed to research, quality, and service, providing innovative products and resources to promote health and wellness. The Associate Director, Regulatory Affairs Strategy – Safety and Toxicology will lead the development and execution of product safety strategies, ensuring compliance and overseeing regulatory submissions for a diverse portfolio of healthcare and consumer products.

Health CareMedicalMedical DeviceTraining

H1B Sponsor Likely

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

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)

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)

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

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

Qualification

Regulatory submissionsSafety strategiesToxicology expertiseFDA regulationsAnalytical skillsCross-functional collaborationProject managementCommunication skillsOrganizational skillsProblem-solving skillsAttention to detailTeamwork

Required

Bachelor's degree in life sciences, pharmacy, or related field required

Solid knowledge of FDA safety regulations

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

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

Preferred

advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus

experience with ex-US authorities (Health Canada) desirable

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

Employee discounts

Sick & safe leave

Vacation

Company & floating holidays

Paid parental leave

Summer hours

Flex place/flex time options

Company

PDI

PDI is dedicated to leading the fight against preventable infections in healthcare, foodservice and our communities.

Founded in 1977

Woodcliff Lake, New Jersey, USA

1001-5000 employees

https://wearepdi.com

H1B Sponsorship

PDI has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)