Regulatory Affairs Associate II

Virtual Company; Plainsboro Center (NJ); In loco; USD 76.000 - 92.000; Tempo pieno

Descrizione del lavoro

The Fountain Group is seeking a Regulatory Affairs Labeling Operations Specialist for a Plainsboro, NJ engagement. The role focuses on labeling development, verification, and lifecycle management, including SPL creation and electronic labeling verification.

This is an onsite‑preferred, remote‑considered 2-year contract with a strong emphasis on FDA/Health Canada compliance and cross‑functional collaboration.

Competenze

• 3–5 years of pharmaceutical regulatory labeling experience.
• Hands-on SPL creation, development, and maintenance.
• Proficiency with TVT or equivalent labeling tools.
• Experience proofreading and reviewing labeling proofs.
• Knowledge of FDA labeling regulations (21 CFR, PLR, SRPI, IFU).
• Experience with regulatory labeling submissions and eCTD processes.
• Proficiency with Veeva Vault RIM, ALiCE, LIFT.
• Knowledge of FDA and Health Canada labeling requirements.
• Independent end-to-end labeling project management.

Mansioni

• Review and proofread labeling artwork, including inserts, cartons and device labels.
• Develop, review, and maintain Structured Product Labeling (SPL) documents and submissions.
• Perform electronic labeling verifications using TVT and other tools.
• Ensure labeling compliance with FDA regulations and applicable requirements.
• Coordinate labeling projects with cross-functional teams.
• Develop project plans, timelines, and risk mitigation strategies.
• Support FDA submissions and product registrations.
• Support labeling process improvements using labeling platforms.

Conoscenze

Pharma labeling experience

SPL creation

TVT proficiency

Proofreading artwork

FDA labeling regulations

eCTD submissions

Veeva Vault RIM

ALiCE

LIFT

FDA & Health Canada labeling

End-to-end project management

Formazione

Bachelor's degree in Regulatory Affairs/Life Sciences/Pharmacy

Minimum 3 years pharma/regulatory experience

Strumenti

TVT (Text Verification Tools)

Descrizione del lavoro

The Fountain Group is currently seeking a Regulatory Affairs Labeling Operations Specialist for a prominent client of ours. This position is located at Plainsboro, NJ (Onsite Preferred; Remote Considered). Details for the position are as follows: Regulatory Affairs Labeling Operations Specialist Location: Plainsboro, NJ (Onsite Preferred; Remote Considered) Pay Rate: $55- $66.48/hr Duration: 2-Year Contract (Extension or Conversion Potential) Schedule: Monday–Friday, 9:00 AM–5:00 PM

Job Description

Seeking an experienced Regulatory Affairs Labeling Operations Specialist to support pharmaceutical labeling development, verification, and lifecycle management for commercial product launches and established brands. The role focuses on proofreading draft and final artwork proofs, Structured Product Labeling (SPL) creation, electronic labeling verification, and regulatory compliance with FDA and Health Canada requirements.

• Review and proofread draft and final printed labeling artwork, including package inserts, leaflets, carton labels, container labels, and device labels.

• Develop, create, review, and maintain Structured Product Labeling (SPL) documents and related regulatory submissions.

• Perform electronic labeling comparisons and verification using Text Verification Tools (TVT) and other comparison systems.

• Ensure labeling compliance with FDA regulations, 21 CFR, Physician Labeling Rule (PLR), and applicable regulatory requirements.

• Coordinate labeling projects with Regulatory Affairs, Graphic Design, Supply Chain, Global HQ, and other cross-functional teams.

• Develop project plans, track timelines, identify project risks, and implement mitigation strategies.

• Support FDA submissions, including SPL Drug Listings, FDA Form 2253, and product/establishment registrations.

• Support labeling process and system improvements using Veeva Vault RIM, LIFT, and other labeling platforms.

Education

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related discipline.

• Minimum 3 years of progressively responsible pharmaceutical, biotechnology, or related industry experience; equivalent education and experience may be considered.

Required Skills

• 3–5 years of pharmaceutical regulatory labeling experience.

• Hands-on experience with Structured Product Labeling (SPL) creation, development, and maintenance.

• Proficiency with Text Verification Tools (TVT) or equivalent electronic labeling comparison tools.

• Experience proofreading and reviewing draft and final pharmaceutical artwork proofs.

• Knowledge of FDA labeling regulations, 21 CFR, PLR, SRPI, Medication Guides, and Instructions for Use (IFUs).

• Experience with regulatory labeling submissions and eCTD processes.

• Proficiency with Veeva Vault RIM, ALiCE, LIFT, and related labeling systems.

• Knowledge of FDA and Health Canada labeling requirements.

• Independent end-to-end project management of labeling activities.

Preferred Skills

• Experience supporting established pharmaceutical brands rather than generic products.

• Experience with ALiCE A4L, novoGlow, Veeva Vault Registrations, and LIFT Artwork Management.

• Experience with FDA portals and systems, including ESG NexGen, FURLS, FDALabel, and Drugs@FDA.

• Knowledge of FDA Form 2253, FDA Establishment Registrations, Annual Reports, SPL Blanket No Change Certification, and Puerto Rico registrations.

• Experience with product lifecycle labeling management and commercial product launches.

• Experience with process and system improvements related to labeling and product/establishment registrations.