Director, Regulatory Affairs

Position

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 provide regulatory guidance throughout the development lifecycle, ensuring alignment with FDA and international regulatory requirements. You will work closely with cross-functional partners to support regulatory submissions, inform development decisions, and advance programs in a compliant, efficient, and high-quality manner. This role 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.

About You

You are a seasoned regulatory affairs professional with strong hands-on experience navigating FDA and international regulatory frameworks. You bring excellent communication, organizational, and problem-solving skills, and are comfortable operating as a strategic individual contributor in a highly collaborative, fast-paced environment. You are confident providing regulatory guidance, managing submissions, identifying risk, and partnering cross-functionally to move programs forward.

What You'll Do

• 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: Partner closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle.
• 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.

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 and guidelines.
• Demonstrated experience contributing to regulatory 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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 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​

The expected salary range for this role is $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.