Regulatory Affairs Associate II

GForce Life Sciences; Plainsboro Township (NJ); Vor Ort; USD 83.000 - 124.000; Vollzeit

Zusammenfassung

GForce Life Sciences is engaged to support a Regulatory Affairs Labeling Operations Specialist (Contractor) in Plainsboro, NJ, onsite preferred with some remote options. The role encompasses final printed labeling for launch and lifecycle management, verification across leaflets, cartons, and device labels, and providing regulatory guidance to ensure CFR/FDA compliance.

Ideal candidates will have a Bachelor's degree and at least 3 years in a pharmaceutical labeling environment, with hands-on

Qualifikationen

• Bachelor’s degree plus minimum 3 years of experience in pharmaceutical labeling or regulatory environment.
• Experience with SPL, ALiCE/A4L and TVT tools.
• Proficiency with 21 CFR labeling, PLR, SRPI, FDA labeling resources and NDCs.
• Ability to independently manage labeling processes and drive outcomes.
• Collaborate effectively with cross-functional teams.

Aufgaben

• Process final printed pharmaceutical labeling tasks for launch and lifecycle projects.
• Perform labeling verification across leaflets, cartons, container labels, and device labels.
• Review commercial labeling materials and provide regulatory guidance for compliance.
• Identify labeling issues and coordinate with stakeholders for timely resolution.
• Monitor improvements to labeling processes, systems, and tools per FDA regulations.

Kenntnisse

Regulatory labeling

Cross-functional collaboration

Attention to detail

Project management

Ausbildung

Bachelor’s degree in life sciences or related field

3+ years labeling/regulatory experience

Tools

SPL (Structured Product Labeling)

ALiCE/A4L

TVT (Text Verification Tool)

Jobbeschreibung

Onsite in Plainsboro, NJ preferred (open to remote).

Summary

Our client has engaged GForce Life Sciences to provide a Regulatory Affairs Labeling Operations Specialist (Contractor) to support final printed pharmaceutical labeling for launch and lifecycle management initiatives, including labeling verification and cross-functional coordination.

Duties/Expectations of the Role

• Process tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects.
• Perform labeling verification, including reviews across leaflets, carton and container labels, and device labels.
• Review commercial labeling materials and provide regulatory guidance to support compliance with CFR and FDA labeling requirements.
• Identify and troubleshoot labeling issues; communicate with stakeholders to drive timely resolution.
• Monitor and recommend improvements to labeling processes, quality, and system tools aligned with FDA regulations and industry best practices.
• Support the final printed labeling review/approval process based on final FDA-approved labeling content.
• Complete additional filing activities as applicable (e.g., SPL drug listing, FDA 2253s, Puerto Rico registrations).
• Use labeling/RA systems and FDA portals/tools (e.g., SPL, ALiCE/A4L, TVT, Vault RIM, Veeva, Esko LIFT, Adobe Acrobat, ESG, NexGen, FURLS).
• Participate on cross-functional teams and contribute to resolution of problems of moderate scope/complexity.
• Support activities including Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA establishment registrations, FDA annual reports, PBRER, Certificate of Pharmaceutical Products, and Puerto Rico registrations.

Mandatory Requirements

• Bachelor’s degree plus minimum 3 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment OR an equivalent combination of education and experience with a concentration in labeling development and maintenance.
• Experience with labeling tools, with emphasis on SPL (structured product labeling), ALiCE/A4L environment, and TVT (Text Verification Tool) usage.
• Proficiency with 21 CFR labeling, PLR, SRPI, FDA patient labeling resources, medication guides, instructions for use, NDCs, and industry labeling trends.
• Ability to independently manage labeling processes, prioritize tasks, and drive outcomes.
• Ability to work effectively with cross-functional teams (Regulatory Affairs, supply chain, design/graphics, marketing, and related stakeholders).