Labeling and Compliance Coordinator

1 week ago


Princeton, New Jersey, United States TK-CHAIN LLC Full time

TITLE: Associate, Regulatory Labeling

JOB SUMMARY

The Associate, Regulatory Labeling plays a critical role in ensuring compliance with FDA regulations and guidelines.

This position involves preparing, reviewing, and submitting regulatory labeling submissions to the FDA, as well as providing guidance and support to internal and external customers.

The ideal candidate will have a strong background in regulatory affairs, excellent analytical and problem-solving skills, and the ability to work effectively in a team environment.

KEY RESPONSIBILITIES

Prepare, review, and submit high-quality regulatory labeling submissions to the FDA.

Provide guidance and support to internal and external customers.

Stay up-to-date with changing FDA regulations and guidelines.

REQUIREMENTS

Bachelor's degree in a scientific discipline or English major.

Minimum of 5 years of experience in the pharmaceutical industry, with at least 2-3 years in regulatory affairs.

Strong analytical and problem-solving skills.

Ability to work effectively in a team environment.

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