Regulatory Affairs Specialist (FDA, DEA )

Regulatory Affairs Specialist (FDA, DEA)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 ResponsibilitiesPrepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates)Oversee and renew DEA registrations, inventory records, and security documentationMaintain state pharmacy, medical device, and wholesale distribution licensesTrack regulatory changes affecting compounding, controlled substances, and labeling requirementsSupport internal audits, site inspections, and responses to 483s or warning lettersCoordinate with Quality Assurance on SOP compliance, change controls, and deviation reportsServe as point of contact with federal and state regulatory agenciesDocument and file compliance records and ensure timely reportingQualificationsAssociate 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 devicesWorking knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and DEA requirementsStrong writing, documentation, and organizational skillsFamiliarity with electronic submission systems, labeling requirements, and drug master filesPreferred SkillsExperience in sterile or non-sterile compounding (503A or 503B environments)Knowledge of NABP license portals, MedWatch reporting, or REMS programsRegulatory Affairs Certification (RAC) or DEA compliance training (preferred)Experience responding to FDA inspections, audits, or state pharmacy board requestsBenefitsHealth, dental, and vision insurance401(k) with employer matchPaid time off and holidaysRegulatory training and continuing education supportAdvancement opportunities into QA/RA leadership roles