Regulatory Affairs Specialist

Responsibilities

• Prepare and manage FDA submissions including drug listings and establishment registrations
• 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
• Support internal audits, site inspections, and responses to 483s or warning letters
• Coordinate with Quality Assurance on SOP compliance and change controls
• Serve as the primary point of contact with federal and state regulatory agencies

Requirements

• Associate degree in Life Sciences, Regulatory Affairs, or related field
• 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 and labeling requirements

Preferred Qualifications

• 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
• Experience responding to FDA inspections 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