PositionWe 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.
About YouYou are a seasoned regulatory affairs professional with strong hands-on experience through clinical regulatory affairs content and strategy, and navigating FDA and international regulatory frameworks. You are comfortable operating as a senior individual contributor who leads programs through influence, partnership, and subject-matter expertise, rather than formal people management. You bring excellent communication, organizational, and problem-solving skills, and thrive in highly collaborative, fast-paced environments where you are expected to both think strategically and execute with rigor.
What You'll Do- 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.
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.
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 $257,250 depending on skills, competency, and the market demand for your expertise.
