Director, Regulatory Affairs

About the role

We 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. This role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs.

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.

Requirements

• Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor’s degree with 12+ 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.

Qualifications

• Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor’s degree with 12+ 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.

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

Pay

The expected salary range for this role is $213,000 to $257,250 depending on skills, competency, and the market demand for your expertise.

Schedule

This role requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office.