AI summary
Director-level Regulatory Affairs role supporting clinical-stage biopharma programs at Eikon Therapeutics, a new biotech using advanced microscopy to unlock novel drug targets. You’ll shape and execute regulatory strategy and submissions (IND/NDA/MAA) while partnering closely with clinical, R&D and quality teams. Standout perk: premiums largely covered (95% medical; 100% dental/vision) plus bonus/equity and seasonal shutdown weeks.
Key skills
Regulatory strategy (clinical-stage development)FDA regulatory requirementsInternational regulatory frameworks (EU, Japan, China)IND submissionsNDA submissionsMAA submissionsCross-functional collaboration (Clinical Development, R&D, Quality)GCP complianceGLP complianceRegulatory risk assessment and mitigation
Salary not listed — comparable Jersey City-area Director/Regulatory Affairs roles typically pay about $190k–$250k base, often with bonus and equity.
You'll thrive here if you’re a seasoned, hands-on regulatory affairs individual contributor who can lead programs through influence and confidently navigate FDA and key international requirements.
Why apply
- Bonus and equity compensation
- 95% medical premiums covered
- Weeklong summer and winter shutdowns
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.
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.
You 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. 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.
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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
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
Daily subsidized lunch program when on-site
Please do not forward unsolicited agency resumes to our website, employees or Human Resources.
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.
You 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. 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.
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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
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
Daily subsidized lunch program when on-site
Please do not forward unsolicited agency resumes to our website, employees or Human Resources.