Director, Regulatory Affairs

The role

The Director, Regulatory Affairs will support and execute regulatory strategy across clinical-stage development programs. This role involves providing regulatory guidance, ensuring alignment with FDA and international requirements, and partnering with cross-functional teams.

What you will do

• Provide strategic and hands-on regulatory support across assigned clinical development programs
• Contribute to the development and execution of regulatory strategies
• Maintain current knowledge of evolving regulations, guidance, and industry best practices
• Lead and/or support the preparation, review, and submission of regulatory documents including INDs, NDAs, and MAAs
• Work closely with Clinical Development, R&D, Quality, and other stakeholders
• Support regulatory aspects of quality systems including compliance with GCP and GLP requirements
• Identify regulatory risks and recommend mitigation strategies

Required 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
• Strong analytical skills, attention to detail, and sound judgment
• Ability to thrive as an individual contributor in a dynamic, high-growth environment

Nice to have

• Prior experience supporting oncology development programs

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

About the company

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.