Regulatory Affairs Technician

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. 

DUTIES/RESPONSIBILIITIES:

Regulatory Labeling Management (Primary Responsibility):

1. 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.
2. 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.
3. Review proposed labeling changes for regulatory impact and ensure alignment with approved ANADAs, NADAs, current CVM expectations, and Pharmgate internal SOPs.
4. 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.
5. Manage label proof review, version control, approval routing, change control support, and reconciliation of final printed labeling against approved regulatory text and artwork specifications.
6. Maintain current and historical labeling archives, including FDA/CVM-approved labeling, supplier proofs, implementation records, obsolete versions, and documentation supporting labeling change history.
7. Track labeling commitments, FDA/CVM correspondence, implementation deadlines, and internal action items to ensure labeling updates are completed on schedule.
8. Provide regulatory labeling guidance to internal stakeholders and support resolution of supplier, artwork, formatting, or content questions related to approved labeling.
9. Monitor relevant FDA/CVM labeling guidance, regulations, and enforcement trends and recommend updates to Pharmgate labeling processes as needed.

Routine Maintenance:

1. Compile and submit annual MCSRs, DERs and Section 105 Antimicrobial reports on time with FDA for all approved products.
2. Complete non-routine filings to FDA/CVM such as original applications, technical sections, supplements, labeling supplements, amendments, and any subsequent response submissions.
3. 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.
4. Review all advertising and promotional material prior to dissemination. File these with FDA as required and ensure promotional claims remain consistent with approved labeling.
5. Ensure compliance with all State licensure and reporting requirements including:
6. Feed license/product registration renewals (state departments of agriculture)
7. Quarterly/Semi-Annual/Annual tonnage reporting requirements
8. Wholesale Distributor/Manufacturer licensure (state boards of pharmacy or equivalent)
9. New applications as applicable and ongoing license renewals
10. Maintenance requirements such as annual self-inspections, scheduling and supporting bi-annual home state inspections, etc.

REQUIRED SKILLS/ABILITIES:

1. Excellent organizational skills and attention to detail.
2. Excellent time management skills with a proven ability to meet deadlines.
3. Strong verbal and written communication skills and the ability to work with all levels of management and vendors.
4. Strong analytical skills, including the ability to read and understand instructions and materials in English.
5. Ability to function well in a high-paced and, at times, stressful environment.
6. Proficient with Microsoft Office Suite, virtual meeting applications, and other related software.
7. Proficient working knowledge of basic spreadsheet functions and word processing

EDUCATION AND EXPERIENCE:

1. Bachelor’s degree in communications, English, document management or business.
2. 1-5 years working in an EPA or FDA regulated industry.
3. 1-4 years working knowledge of Regulatory Affairs in FDA regulated industry.
4. Valid driver’s license and ability to operate a vehicle.
5. Real ID and ability to travel by airplane.

PHYSICAL REQUIREMENTS:

1. Prolonged periods of standing and walking through facilities.
2. Prolonged periods of sitting at a desk working on computers.
3. Must be able to lift up to 40 pounds.
4. Visual acuity to closely inspect regulatory documents, product packaging and product labeling.
5. Ability to occasionally climb stairs.