Regulatory Affairs Labeling Operations Specialist

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.

• 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, involvement in drafting, validation, and error resolution. Tools used (e.g., ALiCE, i4i/iX Forms).
• 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 (~70%).
• Global Labeling Experience
  :
  Total years of global experience and capacity (e.g., global labeling, submissions, alignment with regions).

• 3–5+ years of labeling experience; must also have experience in labeling development.
• SPL preparation and submission experience with minimum 1 year experience in invalidation error resolution.
• Strong technical experience in labeling systems, including:
• TVT (primary system; >50% usage)
• ALiCE/i4i (iXForms) 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

• 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

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.

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.

• 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.

• 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…