Director, Regulatory Affairs

Regulatory Jobs; Jersey City (NJ); On-site; USD 213,000 - 257,000; Full time

Benefits offered by this job

401k plan with company matching

Medical insurance (95%)

Dental insurance (100%)

Vision insurance (100%)

Mental health and wellness benefits

Holiday shutdowns

Paid time off

Life/AD&D insurance (100%)

Parental leave

Lunch on-site

Job summary

Eikon Therapeutics seeks a Director of Regulatory Affairs to shape regulatory strategy and drive hands-on execution across clinical programs. You will provide regulatory guidance throughout the development lifecycle, ensure FDA and international compliance, and partner with cross-functional teams to advance programs in a compliant, efficient, high-quality manner.

This role requires onsite presence in Jersey City, NJ, at least three days per week.

Qualifications

• 10+ years in regulatory affairs for clinical programs.
• Strong experience preparing INDs, NDAs, and MAAs.
• In-depth knowledge of FDA and international guidelines.

Responsibilities

• Provide strategic and hands-on regulatory leadership across clinical programs.
• Drive regulatory submissions and interactions with FDA and global authorities.
• Partner with Cross-functional teams to ensure compliant development and approval plans.
• Maintain up-to-date knowledge of evolving regulations and guidance.

Skills

Regulatory affairs

FDA regulations

Clinical submissions

IND/NDA

Regulatory strategy

Education

Post-graduate degree

Bachelor's + 12 years

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.