Regulatory Affairs Director, Clinical Development

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, 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,