Director, Regulatory Affairs

Date Posted: 8/4/2026

Director, Regulatory Affairs
Hudson County, NJ (Onsite 3 days)
$225K-$255K + bonus and stock

One of our clients, a new biopharmaceutical company, is employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases in the Oncology space.

Description:
They are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner.

Responsibilities:
Program-Focused Regulatory Leadership: Provide strategic and hands-on regulatory support across assigned clinical development programs, partnering closely with cross-functional teams to guide development and regulatory decision-making. Regulatory Strategy: Contribute to the development and execution of regulatory strategies supporting product development, approval, and commercialization in alignment with company objectives. Regulatory Compliance: Maintain current knowledge of evolving regulations, guidance, and industry best practices to ensure ongoing compliance across programs. Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable. Cross-Functional Collaboration: Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment. Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements. Risk Assessment: Identify regulatory risks, assess potential impact, and proactively recommend mitigation strategies.

Required:
Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor’s degree with 10+ years of experience. Strong working knowledge of FDA and international regulatory requirements (including regions such as EU, Japan, China) and guidelines. Demonstrated experience contributing to clinical regulatory content and strategy and managing regulatory submissions. Excellent written and verbal communication skills, with the ability to influence cross-functional stakeholders. Strong analytical skills, attention to detail, and sound judgment. Ability to thrive as an individual contributor in a dynamic, high-growth environment. Prior experience supporting oncology development programs is strongly preferred.

Base salary range for this role is $225,000 to $255,000 plus bonus and stock.

Please contact Darren Gutowski at dgutowski@clarkdavis.com