What are the responsibilities and job description for the Labeling Compliance Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- This is a unique opportunity for a regulatory expert to lead label design and submission efforts for pharmaceutical products and vaccines.
- As a key member of our team, you will be responsible for ensuring accuracy and compliance with FDA and USDA regulations.
- You will work closely with internal stakeholders to revise or draft new packaging for vaccine biologicals, prepare new and revised label packaging for regulatory submissions, and maintain regulatory documents to ensure site compliance.
- Develop and implement labeling strategies to meet regulatory requirements.
- Collaborate with cross-functional teams to ensure accurate and compliant labeling content.
- Review and revise label artwork and designs to ensure consistency and compliance.
- Prepare and submit labeling documents to regulatory bodies in a timely manner.
- Minimum 5-7 years of pharmaceutical labeling experience (Associate degree); 4-6 years of pharmaceutical labeling experience (Bachelor's degree); 2-5 years of pharmaceutical labeling experience (Master's degree).
- Strong background in science or medical terminology, proficiency in Microsoft Office and Adobe software.
