Associate Director, Radiopharmaceutical Regulatory & Safety

COLUMBIA UNIVERSITY IRVING MEDICAL CENTER | DEPARTMENT OF RADIOLOGY; New York (NY); On-site; USD 180,000 - 230,000; Full time

Job summary

Columbia University Irving Medical Center | Department of Radiology seeks an Associate Director, Regulatory & Safety for radiopharmaceutical production, QC, dispensing, and clinical PET imaging. The role ensures FDA compliance, quality systems, and patient safety across manufacturing, operations, and translational programs.

Ideal candidates hold a PharmD with NY licensure, hospital radiopharmacy experience, and expertise in regulatory documentation, GMP standards, and inspection readiness to

Qualifications

• PharmD or equivalent required with licensure in NY.
• Experience with radiopharmaceuticals and regulatory documentation.
• Knowledge of GMP/cGMP and USP requirements.

Responsibilities

• Provide leadership for regulatory compliance, quality systems, and inspections.
• Oversee radiopharmaceutical production, QC, dispensing and clinical PET operations.
• Maintain licenses and regulatory documentation; coordinate FDA inspections.
• Develop SOPs and batch records; ensure patient safety and quality.
• Collaborate with radiochemists, physicians, and safety teams.

Skills

Communication skills

Cross-functional collaboration

Regulatory knowledge

Quality systems understanding

Pharmacist qualification awareness

Education

PharmD or equivalent

New York State pharmacist license or eligibility

Tools

GE FX

FASTlab

Job description

Columbia University Irving Medical Center | Department of Radiology seeks an Associate Director, Regulatory & Safety for radiopharmaceutical production, QC, dispensing, and clinical PET imaging. The role ensures FDA compliance, quality systems, and patient safety across manufacturing, operations, and translational programs.

Ideal candidates hold a PharmD with NY licensure, hospital radiopharmacy experience, and expertise in regulatory documentation, GMP standards, and inspection readiness to