Apply on Employer Site

Cruzader Advanced Recruiting Solutions · 1 month ago

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

North Bergen, NJ

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

8+ years exp

Cruzader Advanced Recruiting Solutions is representing a U.S.-based leader in healthcare and consumer products. They are seeking a seasoned expert to lead product safety, toxicology strategy, and regulatory safety governance across a broad and growing portfolio.

Staffing & Recruiting

Responsibilities

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.)

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

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)

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

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

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

Qualification

ToxicologyRegulatory submissionsSafety strategyAnalytical skillsLeadershipCommunicationProject managementProblem-solvingOrganizational skillsAttention to detail