Senior Oncology Research Regulatory Lead

NYU Langone Health; New York (NY); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health benefits

Wellness program

Generous time-off

Job summary

NYU Langone Health invites applications for a Senior Research Regulatory Specialist. You will lead regulatory activities for oncology clinical trials, supervise up to three staff, and liaise with sponsors, CROs, IRBs, and FDA to ensure compliant, timely activations.

The role emphasizes knowledge of GCP and regulatory guidelines and requires collaboration across departments to support study development and execution at NYU Langone Health.

Qualifications

• Bachelor's degree required; 3 years oncology research experience.
• Working knowledge of government codes/regulations and MS Office suite.

Responsibilities

• Initiate regulatory activities for clinical trials and supervise up to 3 FTEs.
• Serve as liaison between sponsor, CRO, IRB, FDA and internal teams.
• Ensure pre-activation regulatory tasks and timely submissions.

Skills

Regulatory affairs

GCP knowledge

Communication skills

Education

Bachelor's degree

Master's degree preferred

Job description

NYU Langone Health invites applications for a Senior Research Regulatory Specialist. You will lead regulatory activities for oncology clinical trials, supervise up to three staff, and liaise with sponsors, CROs, IRBs, and FDA to ensure compliant, timely activations.

The role emphasizes knowledge of GCP and regulatory guidelines and requires collaboration across departments to support study development and execution at NYU Langone Health.