Regulatory Affairs Specialist FDA DEA

Job Summary

The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of evolving federal and state regulations related to pharmaceuticals, medical devices, and controlled substances.

Key Responsibilities

• Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A / 503B updates)
• Oversee and renew DEA registrations, inventory records, and security documentation
• Maintain state pharmacy, medical device, and wholesale distribution licenses
• Track regulatory changes affecting compounding, controlled substances, and labeling requirements
• Support internal audits, site inspections, and responses to 483s or warning letters
• Coordinate with Quality Assurance on SOP compliance, change controls, and deviation reports
• Serve as point of contact with federal and state regulatory agencies
• Document and file compliance records and ensure timely reporting

Qualifications

Preferred Skills

Benefits

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