Senior Manager / Associate Director, Regulatory Affairs Strategy, Safety and Toxicology (North Bergen)

Company Overview

Our client is a U.S.-based leader in healthcare, consumer products, and regulated formulations, developing and distributing a diverse portfolio spanning infection prevention technologies, medical devices, over the counter (OTC) drugs, cosmetics, sanitizers, disinfectants, and specialty cleaning products.

With multiple R&D and manufacturing sites across the United States, the organization is known for its commitment to innovation, scientific rigor, and product excellence. The team is expanding and seeking a seasoned expert to lead product safety, toxicology strategy, and regulatory safety governance across a broad and growing portfolio.

Position Overview

This person is responsible for developing, implementing, and overseeing the non-clinical safety strategy that supports new product development, regulatory submissions, and the maintenance of marketed products.

This role will lead safety strategy across drugs, medical devices, cosmetics, sanitizers, disinfectants, and other regulated categories, ensuring scientific robustness, regulatory compliance, and on-time delivery of all safety-related documentation.

The ideal candidate blends deep technical expertise, strong regulatory acumen, and hands-on experience with a leadership mindset.

Key Responsibilities

Safety & Toxicology Leadership

• Lead the Product Safety & Toxicology function, guiding safety strategies across early innovation, development, and post-market.
• Develop and execute non-clinical safety plans supporting regulatory submissions, including :
• Investigational New Drug (IND) / New Drug Application (NDA)
• Medical Device 510(k) submissions
• Pesticide registrations under applicable federal frameworks
• Evaluate new ingredients, impurities, and inactive ingredients for safety qualification.
• Oversee the design, monitoring, and interpretation of in vitro and in vivo studies.
• Ensure compliance with Good Laboratory Practice (GLP) and regulatory guidance (U.S. and ex-U.S.).

Regulatory Safety Documentation

Cross-Functional Collaboration

Operational Excellence

Leadership & Mentorship

oRaw material qualification

oSDS generation

oPackaging, fragrance, and nonwoven safety reviews

oManaging third-party safety and environmental certifications (e.g., Safer Choice, USDA Biobased, NEA, EWG)

oFoster scientific excellence, knowledge-sharing, and cross-functional alignment.

Performance Expectations

Qualifications

Education

Experience

Skills & Competencies

Working Conditions

Hybrid schedule : 4 days onsite / 1 day remote in New Jersey.