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

• Associate degree in Life Sciences, Regulatory Affairs, or related field (Bachelor's preferred)
• 2–4 years of regulatory or compliance experience in pharmaceuticals, biotech, or medical devices
• Working knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and DEA requirements
• Strong writing, documentation, and organizational skills
• Familiarity with electronic submission systems, labeling requirements, and drug master files

Preferred Skills

• Experience in sterile or non-sterile compounding (503A or 503B environments)
• Knowledge of NABP license portals, MedWatch reporting, or REMS programs
• Regulatory Affairs Certification (RAC) or DEA compliance training (preferred)
• Experience responding to FDA inspections, audits, or state pharmacy board requests

Benefits

• Health, dental, and vision insurance
• 401(k) with employer match
• Paid time off and holidays
• Regulatory training and continuing education support
• Advancement opportunities into QA/RA leadership roles