FDA Labeling Specialist — Regulatory Submissions & SPL

LanceSoft Inc; Jersey City (NJ); On-site; USD 60,000 - 75,000; Full time

Job summary

A regulatory compliance organization is seeking a Labeling Specialist in Jersey City. This role involves preparing high-quality labeling documents for FDA submissions, proofreading, and managing labeling processes for brand prescription products. Candidates should have 2+ years of experience in pharmaceutical labeling and a solid understanding of FDA regulations. Proficiency in Microsoft Office and good communication skills are essential. This position offers a collaborative environment and opportunities for independent task management.

Qualifications

• 2+ years of pharmaceutical labeling experience.
• Familiarity with medical terminology.
• Basic understanding of FDA labeling regulations.

Responsibilities

• Assist labeling managers with overall labeling process.
• Proofread package insert and packaging components.
• Prepare red‑line documents and comparison charts.
• Complete electronic drug listing and convert label to SPL.
• Maintain and post correct labels on company websites.

Skills

Excellent written communication

Organizational skills

Ability to work independently

Cooperative teamwork

Flexibility in managing priorities

Education

BA/BS with a Scientific or Regulatory background

Tools

Microsoft Office

Excel

Word

Outlook

SharePoint

Job description

A regulatory compliance organization is seeking a Labeling Specialist in Jersey City. This role involves preparing high-quality labeling documents for FDA submissions, proofreading, and managing labeling processes for brand prescription products. Candidates should have 2+ years of experience in pharmaceutical labeling and a solid understanding of FDA regulations. Proficiency in Microsoft Office and good communication skills are essential. This position offers a collaborative environment and opportunities for independent task management.