Regulatory Strategy Director, Biotech Innovations

Eikon; Jersey City (NJ); On-site; USD 235,000 - 289,000; Full time

Benefits offered by this job

401k with match

Medical/dental/vision coverage

Mental health benefits

Summer/Winter shutdowns

Paid time off

Life/AD&D insurance

Enhanced parental leave

Onsite lunch program

Job summary

Eikon Therapeutics in Jersey City, NJ seeks a Senior Director, Regulatory Affairs to lead regulatory strategy and compliance. This role requires onsite presence at least 3 days a week to manage clinical studies and support growth.

Ideal candidate has 12+ years post-degree (or 15+ years with Bachelor) and deep FDA/international regulatory knowledge. You will guide submissions, liaise with agencies, and oversee quality systems in a fast-growing biopharma environment.

Qualifications

• Experience shaping regulatory strategies for product development, approval, and market entry.
• Proven ability to manage INDs, NDAs, and MAAs and liaise with agencies.
• Strong communication, negotiation, and project management skills.
• Experience leading cross-functional teams in a fast-paced environment.

Responsibilities

• Develop and implement regulatory strategies aligned with development plans.
• Monitor evolving regulations and ensure company activities comply with applicable requirements.
• Oversee preparation, review, and submission of regulatory documents (INDs/NDAs/MAAs).
• Provide regulatory guidance to R&D, Quality Assurance, and Clinical Development.
• Supervise quality systems conforming to GCP and GLP.
• Identify regulatory risks and propose mitigation strategies.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

GxP quality systems

FDA/international regulations

Education

Advanced life sciences degree

Job description

Eikon Therapeutics in Jersey City, NJ seeks a Senior Director, Regulatory Affairs to lead regulatory strategy and compliance. This role requires onsite presence at least 3 days a week to manage clinical studies and support growth.

Ideal candidate has 12+ years post-degree (or 15+ years with Bachelor) and deep FDA/international regulatory knowledge. You will guide submissions, liaise with agencies, and oversee quality systems in a fast-growing biopharma environment.