Oncology Regulatory Lead — Remote Options & NDA Strategy

RadNet, Inc.; Northbrook (IL); Hybrid; USD 144,000 - 206,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) match

Annual corporate bonus

Long Term Incentive Plan

Job summary

Astellas in Northbrook, IL is seeking a Regulatory Affairs Lead (Associate Director) to develop regulatory strategy for NDA/NME programs and drive submission activities. The role partners with global teams to shape development plans and ensure compliant submissions.

The ideal candidate has 9+ years in pharmaceutical regulatory affairs, strong FDA/ICH knowledge, and demonstrated leadership on large projects.

Qualifications

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 9 years pharmaceutical drug development experience.
• Regulatory expertise with FDA/ICH regulations.
• Strong organizational skills to manage large projects.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Develop regulatory strategy for NDA/NME planning and submissions.
• Lead and oversee regulatory submissions for assigned projects.
• Interact with FDA and global health authorities on communications.
• Provide regulatory guidance to project teams and stakeholders.
• Mentor Regulatory Affairs staff and contribute to training.

Skills

Regulatory expertise

Regulatory strategy

Project management

Cross-functional collaboration

Communication

Education

Bachelor’s degree in scientific discipline

Advanced degree preferred

Job description

Astellas in Northbrook, IL is seeking a Regulatory Affairs Lead (Associate Director) to develop regulatory strategy for NDA/NME programs and drive submission activities. The role partners with global teams to shape development plans and ensure compliant submissions.

The ideal candidate has 9+ years in pharmaceutical regulatory affairs, strong FDA/ICH knowledge, and demonstrated leadership on large projects.