Senior Regulatory Labeling Specialist — Hybrid

MEITHEAL PHARMACEUTICALS, INC; Chicago (IL); Hybrid; USD 70,000 - 80,000; Full time

Benefits offered by this job

Competitive pay

Medical, dental, and vision insurance

Flexible spending accounts

Disability insurance

Life insurance

401(k) plan with match

Competitive PTO and holidays

Paid parental leave

Employee assistance program

Onsite gym

Hybrid work schedule

Job summary

Meitheal Pharmaceuticals in Chicago, IL, seeks a Senior Associate of Regulatory Affairs, Labeling, to support the labeling function in Regulatory Affairs in compliance with FDA regulations and internal policies.

You will handle daily labeling tasks, maintain SPL and PLR files, contribute to labeling strategy, and ensure timely, accurate documentation, with an emphasis on change controls and quality.

Qualifications

• Bachelor's degree in life sciences; 4+ years related experience.
• Strong understanding of labeling regulations and FDA requirements.
• Proven ability to manage labeling projects and change controls.

Responsibilities

• Perform daily labeling functions in Regulatory Affairs, draft labeling, and update labels.
• Create and maintain SPL and PLR files for accurate product labeling.
• Make strategic labeling decisions and respond to regulatory observations.
• Assess labeling processes for efficiency and continuous improvement.
• Document changes with justification via change controls.
• Meet deadlines and ensure high-quality labeling annotations.

Skills

Regulatory labeling

Documentation & change control

Communication

Quality awareness

Education

Bachelor's degree in life sciences

Tools

SPL/PLR systems

Microsoft Word/Excel

Job description

Meitheal Pharmaceuticals in Chicago, IL, seeks a Senior Associate of Regulatory Affairs, Labeling, to support the labeling function in Regulatory Affairs in compliance with FDA regulations and internal policies.

You will handle daily labeling tasks, maintain SPL and PLR files, contribute to labeling strategy, and ensure timely, accurate documentation, with an emphasis on change controls and quality.