Regulatory Affairs Labeling Operations Specialist
Plainsboro Township, New Jersey
Experience: 3
Category: Scientific & Clinical
Contractor Work Model: Hybrid
Brand: Joulé
Shift: On-Site
Compensation Range: 105000.00 - 110000.00 Per Year
Job ID: 344247
Date Posted: 01/22/2026
Shortcut: http://jobs.systemone.com/J1loMJ
Job Title: Labeling Specialist 344247
Location: Plainsboro, New Jersey
Compensation: $100k-105k annually (dependent on experience)
Type: Full time salaried, 20 days of PTO + 10 Holidays + 401k benefits/etc.
Contractor Work Model: Hybrid preferred but can be fully remote for non-local candidates.
Minimum requirements:
- 3–5+ years of labeling experience
- Labeling development experience
- SPL preparation and submission experience
- Minimum 1 year, including validation error resolution
- Strong technical knowledge of labeling systems, including:
- TVT (primary system; >50% usage)
- ALiCE / i4i (iX Forms)
- SPL tools
- LIFT
- Artwork Software
- Manual proofreading experience (?70% of role)
- Strong attention to detail from an RA perspective
- Familiarity with FDA Patient Labeling Resources and PLR format
- True global labeling experience
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist (Contractor) to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include reviews across the product family of leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain.
Relationships:
Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.
Key Responsibilities:
- Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements
- Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution
- Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices.
Essential Functions:
Label Development:
- Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
- Ensures additional filing requirements are completed for approved content of labeling to include SPL Drug Listing, FDA 2253s and Puerto Rico Registrations
- Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.) as well as coordinating technical support needs with internal IT groups
- Utilizing FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with internal groups and external agencies to resolve any issues
- Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
- Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations
- Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information (SRPI), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations.
- Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel.
- Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices.
- Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.
Ref: #568-Clinical
-
Research Coordinator
Boston, MA
Title: Drug Clinical Research Coordinator Location: Boston MA Schedule: M-F (onsite daily) 8-5 Duration: 6 month contract to hire Pay Rate: $25-$30/hr Start: ASAP Education: Bachelor’s Degree Requirements: 1-3 years of relevant experience in human clin...
Date Posted: 01/05/2026 Recommended
-
Administrative Assistant III
Los Angeles, CA
Job Title: Administrative Assistant III Location: Los Angeles, CA Hours/Schedule: Monday–Friday, 8 am to 5 pm Compensation: $23-$30/hr Type: Contract Overview The Administrative Assistant III provides advanced administrative, organizational, and custom...
Date Posted: 01/15/2026 Recommended
-
Senior Manager, Engineering Plastics Processing
Lakewood, Colorado
Job Title: Senior Manager, Engineering Plastics Processing Location: Onsite - Lakewood, CO (RELOCATION Package available) Type: Direct Hire Salary Range: 160,000 to 200,000 Position Overview The Senior Manager of Engineering Plastics Processing is resp...
Date Posted: 01/07/2026 Recommended
-
Electrical Production Supervisor
Hagerstown, Maryland
Job Title: Electrical Production Supervisor Location: Hagerstown, Maryland Type: Direct Hire Compensation: $75000 - $95000 annually Contractor Work Model: Onsite Hours: 6:30am - 4:00pm System One is seeking an enthusiastic self-motivated Electrical Pro...
Date Posted: 12/18/2025 Recommended
-
Warehouse Operator
Pottstown, PA
Job Title: Warehouse Operator Location: Pottstown, PA Type: Contract Compensation: $24.20 Contractor Work Model: Onsite Hours: 3rd shift – 11pm - 7am Sunday through Thursday Duties and Responsibilities: Responsible for all material control functions in...
Date Posted: 01/06/2026 Recommended
-
Maintenance Supervisor
Freehold, New Jersey
Job Title: Maintenance Supervisor Location: Freehold, NJ Type: Direct Hire Compensation: $65,000-$70,000/yr. Contractor Work Model: Onsite Hours: Monday-Thursday| 7 am till 3:30 pm (Weekend hours as needed) Maintenance Supervisor Job Responsibilities: ...
Date Posted: 01/06/2026 Recommended
-
Handyman
Freehold, New Jersey
Job Title: Handyman Location: Freehold, NJ Type: Direct Hire Compensation: $50,000-$52,000/yr. Contractor Work Model: Onsite Hours: Monday-Thursday| 7 am till 3:30 pm (Weekend hours as needed) Handyman Job Responsibilities: Maintain the day-to-day in t...
Date Posted: 01/06/2026 Recommended
-
Quality Compliance Associate
East Windsor, NJ
Job Title: Quality Compliance Associate Location: East Windsor, New Jersey Type: Contract Compensation: $26 - $36 per hour Contractor Work Model: Onsite Hours: 8/9 AM – 5/6 PM, Monday to Friday Industry: Pharmaceuticals, Sterile Injectable Products Res...
Date Posted: 12/23/2025 Recommended
-
Senior Manager, Supplier Quality
Lakewood, Colorado
Title: Senior Manager, Supplier Quality Location: On-site, Lakewood, CO Schedule: M-F 9:00am- 5:00pm-, hybrid 3 days required to be onsite Pay: $160,000-$200k, 20% bonus (bonus, excellent healthcare benefits, unlimited PTO), relocation assistance Type:...
Date Posted: 01/21/2026 Recommended
-
QC Chemist
Cranbury, NJ
Job Title: QC Chemist Location: Cranbury, NJ Hours / Schedule: Standard business hours; overtime may be required based on project deadlines Type: Contract to Hire with strong intent to convert for the right candidate Compensation: $35 - $36 per hour (s...
Date Posted: 01/09/2026 Recommended
-
Project Manager- Electrical
Norfolk, Virginia
Job Title: Project Manager- Electrical Location: Norfolk, Virginia/Baltimore, MD PROJECT MANAGEMENT Initiate Projects - With a Principal, establish project teams. For assigned projects, complete project initiation documents which include detailed work ...
Date Posted: 12/08/2025 Recommended
-
Principal Investigator - Dermatology North Carolina
concord, North Carolina
Job Title: Clinical Research Physician (Dermatology, PRN) Location: Concord, NC Engagement: PRN / Contract ( approx. 5–10 hours per week) Overview Seeking a US Board Certified Dermatologist, who can function as a Clinical Principal Investigator (PI). T...
Date Posted: 01/02/2026 Recommended
-
Reactor Core and Component System Design Engineer
Bellevue, WA
Job Title: Reactor Core and Component System Design Engineer Location: Bellevue, WA Type: Long-term Contract Compensation: $69 - $115 hourly Contractor Work Model: Remote Position Overview: We are seeking a highly skilled and motivated Reactor Core and...
Date Posted: 12/15/2025 Recommended
-
Reactor Engineer
Jenkinsville, South Carolina
Company: System One Location: Jenkinsville, SC 29065 Work Environment: Onsite – Nuclear Power Plant Employment Type: Direct Hire, Full-Time Relocation Assistance: Available Engineer, Senior Engineer, or Staff Engineer – Reactor Engineering System One i...
Date Posted: 01/08/2026 Recommended
-
Quality Engineer
Orangeburg, NY
Title: Quality Engineer Location: Orangeburg, NY area Start Date: ASAP! Duration: 6 Month Contract (runs through at least the end of July) Hours: Mon-Fri; 8 hour days (5 days a week in office) *flexible start time anywhere between 7am-9am Rate: $38-$43...
Date Posted: 01/21/2026 Recommended
-
Principal Investigator
Walnut Creek, California
Job Title: Clinical Research Physician Location: US Based - Remote Engagement Type : PRN / Contract (approximately 5–10 hours per week) Overview Seeking a US Board Certified Medical Doctor who can serve as a Clinical Principal Investigator (PI). This r...
Date Posted: 01/02/2026 Recommended
-
Equipment Qualification Engineer – Seismic & Environmental (Nuclear)
Oak Ridge, Tennessee
Job Title: Equipment Qualification Engineer – Seismic & Environmental (Nuclear) Location: Oak Ridge, Tennessee Type: Direct Hire Work Model: Onsite System One is seeking an experienced Equipment Qualification (EQ) Engineer with a strong background in s...
Date Posted: 01/18/2026 Recommended
-
Food Ingredients Quality Document Associate
Morristown, New Jersey
Job Title: Food Ingredients Quality Document Associate Location: Florham Park area (Hybrid) Hours / Schedule: 9am - 5pm Type: Direct Hire The Food Ingredients Quality Document Associate will support Quality and Regulatory functions by coordinating tech...
Date Posted: 01/20/2026 Recommended
-
Global Operational Excellence Lead
Lakewood, CO
Job Title: Global Operational Excellence Lead Type: Direct Hire Location: Remote with travel up to 30% international Salary Range: $116,000 to $146,000/year plus 7% bonus Overview: Global Medical Device Company is seeking a strategic Operational Excell...
Date Posted: 12/09/2025 Recommended
-
Electrical Final Assembler
Salt Lake City, Utah
Job Title: Electrical Final Assembler Location: Salt Lake City, Utah Type: Contract To Hire Contractor Work Model: Onsite As an Electric Final Assembler you are responsible for proper assembly of all wiring and electrical components in the project. You...
Date Posted: 01/07/2026 Recommended
-
Principal Investigator / Sub-Investigator - Cardiology Mississippi
Diamondhead, Mississippi
Clinical Research Physician (Cardiology, PRN) Location: Diamondhead, MS Engagement Type: PRN / Contract (approximately 5–10 hours per week) Onsite Requirement: Yes Overview The Principal Investigator (PI) provides medical leadership and overall oversig...
Date Posted: 12/04/2025 Recommended
-
Senior Engineer
Bellevue, Washington
System One is seeking an experienced Senior Mechanical Engineer to support the design and development of reactor structures and components for a next-generation Generation IV advanced nuclear reactor program. This role is focused on high-integrity nucl...
Date Posted: 01/05/2026 Recommended
-
OSP Engineer
Everett, WA
Mountain Ltd. has an opening for an OSP Engineer, working in the Everett,, WA area. Since 1979, Mountain Ltd. has successfully created and supported turnkey engineering solutions for traditional and wireless telecom providers across the United States. ...
Date Posted: 11/18/2025 Recommended
-
OSP Engineer
Mount Vernon, WA
Mountain Ltd. has an opening for an OSP Engineer, working in the Mount Vernon, WA area. Since 1979, Mountain Ltd. has successfully created and supported turnkey engineering solutions for traditional and wireless telecom providers across the United Stat...
Date Posted: 11/18/2025 Recommended
-
OSP Engineer
Tacoma, WA
Mountain Ltd. has an opening for an OSP Engineer, working in the Pierce/Thurston Counties area. Since 1979, Mountain Ltd. has successfully created and supported turnkey engineering solutions for traditional and wireless telecom providers across the Uni...
Date Posted: 11/18/2025 Recommended
-
OSP Engineer
Edmonds, WA
Mountain Ltd. has an opening for an OSP Engineer, working in the Edmonds,, WA area. Since 1979, Mountain Ltd. has successfully created and supported turnkey engineering solutions for traditional and wireless telecom providers across the United States. ...
Date Posted: 11/18/2025 Recommended
-
Senior Production Technician
Jersey City, New Jersey
Title: Senior Production Technician Location: Jersey City, New Jersey Shift: Monday to Friday, 8 am-4 pm, onsite Salary: $50,000 - $70,000 annually (based on experience) / Exempt position Type: Direct Hire The Senior Production Technician performs dail...
Date Posted: 01/16/2026 Recommended
-
Ingredient Compliance Specialist
Parsippany, New Jersey
Job Title: Ingredient Compliance Specialist Type: Direct Hire Location: Morris County, NJ (Whippany/Parsippany, NJ) Schedule: Hybrid | 9:00 a.m.–5:00 p.m. Salary: $70,000–$85,000 + performance bonus About the Opportunity We are seeking an Ingredient Co...
Date Posted: 01/20/2026 Recommended
-
IPQA II
East Windsor, New Jersey
Job Title: IPQA II Location: East Windsor, New Jersey Type: Direct Hire Compensation: $24 - $28 annually Contractor Work Model: Onsite Hours: 7 AM- 3:30 PM M-F (available for overtime, including weekends, as needed for production support) Responsibilit...
Date Posted: 01/14/2026 Recommended
-
Business Operations Analyst
Vienna , VA
Job Title: Business Operations Analyst Location: Hybrid Work Model Reporting to San Antonio, TX Pay Rate: Open to Both C2C and W2 options Position Type: Multiyear Contract This role will be Monday and Tuesday in the office in SA, Texas and will work th...
Date Posted: 01/08/2026 Recommended