Regulatory Affairs Specialist - Labeling

Danaher; New York (NY); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Labeling Specialist to manage labeling processes and ensure compliance with regulatory standards. This role involves collaboration with various teams and requires significant experience in drug product labeling. Join a dynamic team focused on advancing science and improving human health.

Qualifications

• 5+ years of relevant experience in drug product labeling.
• Experience with labeling equipment qualification is preferred.

Responsibilities

• Manage all labeling activities across the product lifecycle.
• Ensure compliance with FDA and EU labeling regulations.
• Collaborate with Regulatory Affairs and Quality Assurance teams.

Skills

Compliance

Process Improvement

Collaboration

Education

Bachelor’s Degree in Life Sciences

Job description

Job Description: Labeling Specialist at Aldevron

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our dedicated team combines best-in-class products and services with an ideal operating environment to foster vital discoveries worldwide. We believe our people are our most valuable asset. Whether you're starting your career or are a seasoned professional, we hire from all backgrounds and experiences.

Aldevron is part of Danaher’s Life Sciences sector. Together, we accelerate solutions that safeguard and improve human health.

This position is based in Fargo, ND, and is on-site. You will join the Operational Quality Assurance team, reporting to the Sr. Manager, Operational QA. Your role involves developing and implementing labeling processes and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to ensure labeling strategies meet regulatory and branding standards.

This is a remote position with frequent travel to Fargo, ND.

Key Responsibilities:

1. Manage all labeling activities across the product lifecycle, including creation, approval, and reconciliation of labels and artwork, coordinating with stakeholders and vendors.
2. Ensure labeling content, format, and placement comply with applicable regulations such as 21 CFR Parts 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, Q9, Q10, and international guidelines.
3. Develop and maintain robust labeling processes to ensure compliance, accuracy, and consistency, including document control and change management.
4. Collaborate closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams to align on labeling requirements and manage artwork creation and version control.
5. Stay updated on industry trends, regulations, and best practices, and identify opportunities for process improvements and automation.

Minimum Requirements:

• 5+ years of relevant experience in drug product labeling.
• Experience with labeling equipment qualification and process validation is preferred.
• Bachelor’s Degree, preferably in a life sciences field.
• Proven compliance with cGMP and GDP standards.
• Strong knowledge of FDA and EU labeling regulations, including 21 CFR Parts 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, Q9, Q10.

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Join our team to help accelerate the impact of science and technology. We partner globally to solve complex challenges, bringing science to life.

For more information, visit www.danaher.com.

Danaher Corporation and its affiliates are committed to equal opportunity employment and value diversity in our workforce. For accommodations during the application process, contact [e-mail].