Regulatory & Safety Leader, PET Center

NVSHP; New York (NY); On-site; USD 190,000 - 215,000; Full time

Job summary

Columbia University PET Center seeks an Associate Director, Regulatory & Safety, to lead regulatory and quality oversight of radiopharmaceutical production and clinical PET operations. You will ensure FDA compliance, manage licensing, and collaborate with radiochemists, physicians, and institutional offices to maintain the highest standards of patient safety.

The role requires a PharmD with substantial experience in hospital or radiopharmacy settings, familiarity with GMP, inspection readiness,

Qualifications

• PharmD or equivalent professional pharmacy degree.
• Current NYS pharmacist license or eligibility.
• Significant hospital/nuclear/radiopharmacy experience.
• Understanding of radiopharmaceuticals and clinical PET operations.
• Experience with regulatory documentation, quality systems, and inspections.
• Familiarity with GMP and USP requirements.

Responsibilities

• Provide pharmacy oversight for radiopharmaceutical procurement, preparation, dispensing, and administration.
• Lead regulatory compliance activities and FDA inspections readiness.
• Develop and implement SOPs and QA processes for PET radiopharmaceutical operations.
• Maintain licenses, registrations, and regulatory documentation.
• Oversee quality control, batch records, deviations, CAPA, and investigations.
• Collaborate with radiochemists, physicians, physicists, and regulatory offices.

Skills

Regulatory compliance

FDA submissions

Quality systems

Communication

Cross-functional collaboration

Education

PharmD or equivalent

Tools

GE FX

FASTlab

Job description

Columbia University PET Center seeks an Associate Director, Regulatory & Safety, to lead regulatory and quality oversight of radiopharmaceutical production and clinical PET operations. You will ensure FDA compliance, manage licensing, and collaborate with radiochemists, physicians, and institutional offices to maintain the highest standards of patient safety.

The role requires a PharmD with substantial experience in hospital or radiopharmacy settings, familiarity with GMP, inspection readiness,