Director, Regulatory Affairs
About The Position
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. 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.
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 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.
Responsibilities
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
