Head of Regulatory & Safety, PET Center

Columbia University Irving Medical Center; New York (NY); On-site; USD 190,000 - 215,000; Full time

Job summary

Columbia University Irving Medical Center is seeking an Associate Director of Regulatory & Safety for the PET Center. The role leads radiopharmaceutical production oversight, quality systems, and regulatory compliance, ensuring FDA and state regulations are met.

Collaboration with radiochemists, physicians, physicists, and regulatory offices is essential. You will manage documentation, licensing, CAPA, and inspection readiness, contributing to a cutting-edge PET program and safe, compliant

Qualifications

• Doctor of Pharmacy (PharmD) or equivalent.
• Current New York State pharmacist license or eligibility.
• Experience in hospital or radiopharmacy settings.
• Knowledge of regulatory documentation and quality systems.
• Experience with FDA inspections or regulatory submissions.
• Familiarity with radiopharmaceutical production and PET operations.
• Ability to coordinate across clinical, scientific, and regulatory teams.

Responsibilities

• Provide pharmacy leadership for radiopharmaceutical procurement, preparation, dispensing, and administration in clinical PET.
• Collaborate with physicians and technologists to ensure timely radiopharmaceutical use for imaging.
• Develop and implement SOPs and quality processes for clinical radiopharmaceutical operations.
• Lead patient-safety and QA processes for radiopharmaceutical handling and PET operations.
• Support integration of new radiopharmaceuticals into clinical practice.

Skills

Pharmacist leadership

FDA compliance

cGMP knowledge

Regulatory documentation

Radiopharmaceuticals

Quality systems

Education

Doctor of Pharmacy (PharmD)

New York pharmacist license (eligibility)

Tools

GE FX

FASTlab

Job description

Columbia University Irving Medical Center is seeking an Associate Director of Regulatory & Safety for the PET Center. The role leads radiopharmaceutical production oversight, quality systems, and regulatory compliance, ensuring FDA and state regulations are met.

Collaboration with radiochemists, physicians, physicists, and regulatory offices is essential. You will manage documentation, licensing, CAPA, and inspection readiness, contributing to a cutting-edge PET program and safe, compliant