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Senior Manager/Associate Director, Regulatory Affairs Strategy, Safety and Toxicology
Senior Manager/Associate Director, Regulatory Affairs Strategy, Safety and ToxicologyCruzader Advanced Recruiting Solutions • North Bergen, NJ, US
Senior Manager / Associate Director, Regulatory Affairs Strategy, Safety and Toxicology

Senior Manager / Associate Director, Regulatory Affairs Strategy, Safety and Toxicology

Cruzader Advanced Recruiting Solutions • North Bergen, NJ, US
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  • [job_card.full_time]
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Job Description

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

  • Author and review non-clinical safety sections for :
  • IND / NDA submissions
  • 510(k) medical device filings
  • Pesticide regulatory submissions
  • Deliver toxicological risk assessments, safety clearances, and Consumer Product Safety Reviews (CPSR).
  • Oversee the creation and accuracy of Safety Data Sheets (SDS) across multiple product categories.

    • Cross-Functional Collaboration

  • Serve as the safety representative across R&D, Clinical, Manufacturing, Quality, and New Product Development.
  • Advise teams on safety concerns, study design, and risk mitigation.
  • Support regulatory authority interactions (e.g., FDA, Health Canada).

    • Operational Excellence

  • Maintain and improve safety documentation, assessment templates, and internal SOPs.
  • Lead initiatives to enhance process efficiency, accuracy, and compliance.
  • Support claims including allergen statements, non-animal testing, and “free-from” declarations.

    • Leadership & Mentorship

    o  Raw material qualification

    o  SDS generation

    o  Packaging, fragrance, and nonwoven safety reviews

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

    o  Foster scientific excellence, knowledge-sharing, and cross-functional alignment.

    Performance Expectations

  • Deliver high-quality, accurate, regulatory-compliant safety outputs on schedule.
  • Demonstrate scientific judgment, ownership, and proactive problem-solving.
  • Influence decision-making across cross-functional teams without formal authority.
  • Contribute innovative solutions and lead continuous improvement initiatives.

    • Qualifications

    Education

  • Bachelor’s degree in Life Sciences required.
  • Advanced degree (PhD, PharmD, MS) strongly preferred.
  • Toxicology certifications (DABT, CCCTO) are a plus.

    • Experience

  • 8–10+ years in toxicology, product safety, or regulatory safety roles.
  • Experience with regulatory submissions :
  • IND / NDA
  • Medical Device 510(k)
  • Pesticide registrations
  • Strong familiarity with U.S. and Canadian safety regulations.

    • Skills & Competencies

  • Exceptional written and verbal communication.
  • Strong analytical, organizational, and leadership abilities.
  • Ability to manage multiple projects in fast-paced, matrixed environments.
  • High attention to detail with strong problem-solving skills.
  • Independent, decisive, and comfortable interfacing with stakeholders at all levels.

    • Working Conditions

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

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