Assoc Dir, Regulatory Strategy Safety & Toxicology

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! 

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.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Contributions

• 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

Oversee 1 direct report to:

• 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 52^nd Amendment (2026), Hazard Communication Standard (SDS) Updates; California CFFIRKA allergen reporting requirements)

Cross-Functional Support

• 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.

Operational Excellence

• 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.

Mentorship and Collaboration

• Provide guidance and support to junior regulatory staff where applicable, 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 technical work with minimal issues
• 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

QUALIFICATIONS

EDUCATION/CERTIFICATION

• Bachelor’s degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus

REQUIRED KNOWLEDGE

• 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

EXPERIENCE REQUIRED

• 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

SKILLS/ABILITIES

• 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

WORKING CONDITIONS

Environment: Corporate office with on-site R&D laboratories

Work Schedule: Hybrid (4-days/week onsite, 1-day/week remote)

SALARY RANGE:

• $150,000 - $180,000 annually

BENEFITS

 PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• 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

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

 At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including:  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.

Salary : $150,000 - $180,000