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$50k–$65k/yr
Full-time
bachelor degree
Posted 6h ago
~40 hrs/week
Responsibilities
The Regulatory Affairs Technician manages product labeling responsibilities, including FDA/CVM submissions, label content maintenance, and compliance oversight. They also handle routine filings, state registrations, and support internal stakeholders with regulatory guidance.
Requirements
Candidates must hold a bachelor's degree in communications, English, document management, or business. The role requires 1-5 years of experience in an EPA or FDA regulated industry, with 1-4 years specifically in Regulatory Affairs.
Full job description
Description
Job Title: Regulatory Affairs Technician
Reports To: VP Regulatory Affairs & Product Development
Department: Regulatory Affairs
Location: Wilmington, NC
Classification: Exempt, Full Time
JOB SUMMARY:
The primary focus of this position is to manage Pharmgate regulatory labeling responsibilities, including FDA/CVM labeling submissions, label content maintenance, coordination with label suppliers and internal stakeholders, and oversight of labeling compliance throughout the product lifecycle. Additional responsibilities include handling routine and non-routine filings to FDA/CVM, maintaining regulatory files, supporting pharmacy licensing and state registrations, and performing other Regulatory Affairs tasks as assigned.
Serve as Pharmgate's primary Regulatory Affairs owner for product labeling, including package inserts (if applicable), container labels, carton/bag labels, Type A medicated article labeling, blue bird labels, and related regulatory labeling records.
Prepare, coordinate, and submit FDA/CVM labeling submissions, including original or revised labeling, supplements, amendments, responses to CVM labeling comments, and other labeling-related submissions as applicable.
Review proposed labeling changes for regulatory impact and ensure alignment with approved ANADAs, NADAs, current CVM expectations, and Pharmgate internal SOPs.
Coordinate labeling revisions with label suppliers, printers, artwork vendors, Quality, Operations, Supply Chain, Commercial/Marketing, and Manufacturing to ensure accurate, compliant, and timely implementation of approved labeling.
Manage label proof review, version control, approval routing, change control support, and reconciliation of final printed labeling against approved regulatory text and artwork specifications.
Maintain current and historical labeling archives, including FDA/CVM-approved labeling, supplier proofs, implementation records, obsolete versions, and documentation supporting labeling change history.
Track labeling commitments, FDA/CVM correspondence, implementation deadlines, and internal action items to ensure labeling updates are completed on schedule.
Provide regulatory labeling guidance to internal stakeholders and support resolution of supplier, artwork, formatting, or content questions related to approved labeling.
Monitor relevant FDA/CVM labeling guidance, regulations, and enforcement trends and recommend updates to Pharmgate labeling processes as needed.
Routine Maintenance:
Compile and submit annual MCSRs, DERs and Section 105 Antimicrobial reports on time with FDA for all approved products.
Complete non-routine filings to FDA/CVM such as original applications, technical sections, supplements, labeling supplements, amendments, and any subsequent response submissions.
Assist with archiving and handling ongoing electronic submission responsibilities such as sending items through the Gateway, monitoring the ESG NextGen inbox for FDA correspondence, and updating the electronic archives on the shared drive.
Review all advertising and promotional material prior to dissemination. File these with FDA as required and ensure promotional claims remain consistent with approved labeling.
Ensure compliance with all State licensure and reporting requirements including:
Feed license/product registration renewals (state departments of agriculture)
Profile
We provide a range of services, which helps companies to manage every stage of the process from design to launch pharmaceutical or other type medical products in the area of interest in our region, including the development of regulatory and clinical strategy, preparation and management of its approval.
After launch products on the market, our company also provides all the functions needed in the future product life cycle management.
For the successful path of the product on the market of medical products must be effective in:
Support the product life cycle - approval for medical use & management of product modifications
Pharmacovigilance and safety monitoring
Organization and support of clinical trials II-IV phase
Marketing and post-marketing studies
Education and Training for personnel and specialists.
Our company is focused on providing project management for key parts of the project or its phases, various aspects of technical support - translation, documentation, support the process of approval, modification, development, adaptation and implementation of consumer packaging, research and product testing in laboratory conditions, the interaction with Interested services to supply, the input quality control and monitoring of the market.
Offices: The Brentano Suite Solar House 915 High Road, Suite N 36, London N12 8QJ, N12 8QJ, GB
Regulatory AffairsPersonnel training and educationPharmacovigilenceand Life Cycle managementTrainingManagement ConsultingPharmaceutical