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Regulatory Affairs Labeling Operations Specialist

Joulé

Plainsboro Township, NJ(remote)

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JOB DETAILS
SALARY
$105,000–$110,000 Per Year
SKILLS
Adobe Acrobat, Alice Programming Language, Best Practices, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Corporate Compliance, Cross-Functional, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Graphic Design, Help Desk, Identify Issues, Industry Standards, Industry/Trade Analysis, Interpersonal Skills, Maintain Compliance, Marketing, Medications, Negotiation Skills, Operations Management, Outsourcing, Problem Solving Skills, Process Management, Product Reviews, Product/Service Launch, Project Lifecycle, Project Planning, Project/Program Coordination, Proofreading, Regulations, Service Delivery, Supply Chain, Team Player, Technical Leadership, Technical Support, Time Management, Training/Teaching
LOCATION
Plainsboro Township, NJ
POSTED
8 days ago
Job Title: Labeling Specialist
Location: Plainsboro Township, New Jersey
Compensation: $100k-120k annually, FTE + 20 days of PTO + 10 Holidays - 401k benefits/etc.
Open to discuss higher salaries with candidates meeting and exceeding requirements.
Work Model: Hybrid but can be fully remote for non-local candidates.


Highlighted requirements candidates must be able to speak to:
Labeling Experience: Total years of labeling experience and type of labeling (development, maintenance, submissions)
SPL Experience: Total years of SPL experience (minimum 1 year required). Where SPL work was performed (company/role). Involvement in drafting, validation, and error resolution. Tools used (e.g., ALiCE, i4i/iX Forms).
Text Verification Tool (TVT) Experience: Total years using TVT. Systems used (e.g., TVT / ALiCE). Percentage of role spent using TVT. Experience troubleshooting and resolving TVT issues independently
Proofreading Experience: Total years of manual proofreading. Where and how proofreading was performed. Approximate % of role dedicated to proofreading (role is ~70%)
Global Labeling Experience: Total years of global experience and capacity (e.g., global labeling, submissions, alignment with regions)

The right candidate will have the following experience:
  • 3–5+ years of labeling experience; must also have experience in labeling development.
  • SPL preparation and submission experience with minimum 1 year experience in validation error resolution
  • Strong technical experience in labeling systems, including:
  • TVT (primary system; >50% usage)
  • ALiCE / i4i (iX Forms) and SPL tools
  • LIFT
  • Artwork Software
  • Manual proofreading experience (>70% of role)
  • Familiarity with FDA Patient Labeling Resources and PLR format
  • True global labeling experience

Nice to Have / Value Adds
  • Artwork software experience
  • Ability to teach or guide others on TVT
  • Tech-savvy mindset with ability to pick up new systems quickly
  • Experience in branded pharma environments

Job Description:
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

Labeling Tools:
  • 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

Regulatory Support:
  • 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

Skills and Experience:
  • 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 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.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical


About the Company

J

Joulé

With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

  • Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

  • Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

  • Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

  • National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/