Regulatory & Safety Lead, PET Center

Association of University Radiologists; New York (NY); In loco; USD 190.000 - 215.000; Tempo pieno

Descrizione del lavoro

Columbia University Irving Medical Center is seeking an Associate Director, Regulatory & Safety for the PET Center. This role leads regulatory affairs, quality systems, and radiopharmaceutical operations, ensuring FDA compliance and patient safety across production, testing, and clinical PET workflows.

The successful candidate will collaborate with radiochemists, physicians, physicists, and regulatory offices to maintain inspection readiness and implement robust quality documentation for

Competenze

• PharmD degree and NY pharmacist license or eligibility.
• Significant hospital/nuclear pharmacy/radiopharmacy experience.
• Knowledge of FDA/regulatory requirements for radiopharmaceuticals.
• Experience with GMP/cGMP and regulatory documentation.
• Experience supporting FDA inspections or regulatory submissions.
• Strong written and verbal communication across clinical/scientific/regulatory teams.

Mansioni

• Provide leadership for PET radiopharmaceutical operations, procurement, preparation, dispensing, and administration.
• Oversee radiopharmaceutical manufacturing, QA, and documentation processes.
• Serve as regulatory expert for FDA compliance, inspections, and licensing activities.
• Collaborate with Radiation Safety, radiochemistry, and clinical teams to ensure safety and compliance.
• Support translational and investigational radiopharmaceutical programs and IND-related activities.

Conoscenze

FDA regulatory compliance

Quality systems

Regulatory documentation

Cross-functional collaboration

Communication skills

Formazione

Doctor of Pharmacy (PharmD) or equivalent

Strumenti

GE FX

FASTlab

Automated radiochemistry systems

Descrizione del lavoro

Columbia University Irving Medical Center is seeking an Associate Director, Regulatory & Safety for the PET Center. This role leads regulatory affairs, quality systems, and radiopharmaceutical operations, ensuring FDA compliance and patient safety across production, testing, and clinical PET workflows.

The successful candidate will collaborate with radiochemists, physicians, physicists, and regulatory offices to maintain inspection readiness and implement robust quality documentation for