Regulatory Affairs Technician
$50,000–$65,000 year
On-siteWilmington, North Carolina, United States
Job Summary
Manage Pharmgate regulatory labeling responsibilities, including FDA/CVM submissions, label content maintenance, and oversight of compliance throughout the product lifecycle. Prepare, coordinate, and submit labeling changes, supplements, and amendments while reviewing proposed revisions for regulatory impact and alignment with approved ANADAs and internal SOPs. Coordinate labeling revisions with suppliers, printers, and internal stakeholders to ensure accurate implementation, maintain current and historical labeling archives, and track commitments and deadlines. Compile and submit annual MCSRs, DERs, and antimicrobial reports to the FDA, handle non-routine filings, and ensure compliance with state licensure and reporting requirements.
Required Qualifications
- Bachelor's degree in communications, English, document management or business
- 1-5 years working in an EPA or FDA regulated industry
- 1-4 years working knowledge of Regulatory Affairs in FDA regulated industry
- Valid driver's license and ability to operate a vehicle
- Real ID and ability to travel by airplane
- Must be able to lift up to 40 pounds
- Visual acuity to closely inspect regulatory documents, product packaging and product labeling
- Ability to occasionally climb stairs
Desired Qualifications
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Strong verbal and written communication skills and the ability to work with all levels of management and vendors
- Strong analytical skills, including the ability to read and understand instructions and materials in English
- Ability to function well in a high-paced and, at times, stressful environment
- Proficient with Microsoft Office Suite, virtual meeting applications, and other related software
- Proficient working knowledge of basic spreadsheet functions and word processing
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