Director, Regulatory Affairs

Eikon Therapeutics, Inc.; Jersey City (NJ); Hybrid; USD 213,000 - 257,000; Full time

Benefits offered by this job

401k plan with company matching

Medical, dental and vision insurance (

Mental health benefits

Weeklong summer and winter shutdowns

Generous paid time off

Life/AD&D insurance

Enhanced parental leave

Daily subsidized lunch on-site

Job summary

Eikon Therapeutics, Inc. seeks a Director of Regulatory Affairs to shape and execute regulatory strategy across our clinical development programs.

This role requires hands-on leadership and collaboration with cross-functional teams to advance programs in compliance with FDA and international requirements, based in our Jersey City, NJ office. You will operate as a senior individual contributor, contributing to oncology programs with a strong track record in regulatory submissions and strategy,

Qualifications

• 10+ years of regulatory affairs experience or 12+ years with a Bachelor’s degree.
• Deep knowledge of FDA and international regulatory requirements (EU, Japan, China).
• Experience contributing to clinical regulatory content and submissions.
• Excellent written and verbal communication with cross-functional influence.
• Ability to thrive as an individual contributor in a high-growth environment.
• Prior oncology regulatory experience is strongly preferred.

Responsibilities

• Provide strategic and hands-on regulatory support across clinical development programs.
• Develop and execute regulatory strategies for development, approval, and commercialization.
• Maintain current knowledge of evolving regulations and ensure ongoing compliance.
• Lead and/or support preparation, review, and submission of regulatory documents (INDs, NDAs, MAAs).
• Collaborate with Clinical Development, R&D, Quality and other stakeholders.
• Support regulatory aspects of quality systems including GCP/GLP compliance.
• Identify regulatory risks and propose mitigation strategies.

Skills

Regulatory leadership

FDA knowledge

Cross-functional influence

Regulatory strategy

Communication skills

Strategic thinking

Individual contributor

Oncology experience

Education

Post-graduate degree in life sciences

Bachelor's degree in life sciences

Job description

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 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 You

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. 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.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.