Regulatory Affairs & Compliance Manager, PET Production Facility
Core
Ensures regulatory compliance and quality management for an FDA-registered PET radiopharmaceutical manufacturing facility, managing cGMP documentation, investigations, and vendor relations.
Role type
Regulatory Affairs & Compliance Manager
Builds
FDA-registered PET radiopharmaceuticals for clinical and research use
Domain
Healthcare / Nuclear Medicine / cGMP Manufacturing
Deliverable
client delivery
Required skills
cGMP compliance, quality improvement methodologies, FDA regulation interpretation, OOS investigation, CAPA management, change control, vendor complaint handling, IND submission support, environmental monitoring, equipment IQ/OQ review, training program oversight
Preferred skills
Quality management certification, pharmaceutical science background, regulatory affairs experience, supervisory experience
Technologies
None explicitly stated
Responsibilities
Author and review standard operating procedures and cGMP documents; coordinate OOS investigations; manage CAPA and change control; maintain FDA and state regulatory compliance; oversee personnel training; collaborate with production staff on quality investigations; manage vendor relationships and facility repairs documentation
Seniority
Mid-level Manager, hands-on operational leadership
