Senior Regulatory Labeling Specialist (Hybrid)

Meitheal-Pharmaceuticals-Inc.; Chicago (IL); Hybrid; USD 70,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with match

Paid holidays

Paid parental leave

Hybrid work schedule

Onsite gym

Flexible spending accounts

Job summary

Meitheal Pharmaceuticals in Chicago seeks a Senior Associate of Regulatory Affairs, Labeling, to support labeling functions in regulatory compliance with FDA rules and internal policies. You will manage draft labeling, SPL/PLR files, and defensible labeling decisions with attention to quality and deadlines.

The role requires a life sciences degree and experience in regulatory labeling; strong writing and analytical skills are essential, along with proficiency in MS Office tools.

Qualifications

• Bachelor's degree in life sciences and related experience.
• Ability to read, analyze, and interpret regulations and procedures.
• Strong written and verbal communication for regulatory dossiers.
• Proficiency with MS Office and document management tools.

Responsibilities

• Performs daily labeling functions in Regulatory Affairs, drafting and revising labels.
• Creates and maintains SPL and PLR files for accurate rendering.
• Makes strategic decisions regarding labeling content and patents.
• Assesses labeling processes for efficiency and improvement.
• Formats labeling annotations and deficiency responses.
• Meets deadlines and ensures high-quality documentation.
• Proofreads and annotates label copy to standards.
• Documents changes with appropriate change controls.

Skills

Analytical reading

Written communication

Oral communication

Problem solving

Attention to detail

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

PowerPoint

Excel

Adobe Illustrator

DocuProof

Barcode Studio

Job description

Meitheal Pharmaceuticals in Chicago seeks a Senior Associate of Regulatory Affairs, Labeling, to support labeling functions in regulatory compliance with FDA rules and internal policies. You will manage draft labeling, SPL/PLR files, and defensible labeling decisions with attention to quality and deadlines.

The role requires a life sciences degree and experience in regulatory labeling; strong writing and analytical skills are essential, along with proficiency in MS Office tools.