Regulatory Affairs Specialist – Labeling

At Aldevron, we shape the future of medicine

We advance science in meaningful ways. Our team of dedicated, forward-thinking associates shares this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or you’re a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Part of the Danaher Life Sciences platform

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development, and delivery of solutions that safeguard and improve human health.

About the position

This position is part of Quality Assurance located in Fargo, ND and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
You will be a part of the Operational Quality Assurance team and report to the Sr. Manager, Operational QA. This role is responsible for developing and implementing labeling processes and procedures and collaborating with cross-functional teams—including Clients, Regulatory Affairs, and Marketing—to develop labeling strategies that align with regulatory requirements and company branding.

In this role, you will have the opportunity to:

• Manage labeling activities throughout the product lifecycle: Oversee the creation, approval, and implementation (including reconciliation) of labels and labeling artwork, including primary, secondary, and packaging components. Coordinate with internal stakeholders and external vendors to ensure timely and accurate labeling production, including translations, barcodes, and serialization.
• Ensure compliance: Ensure that labeling content, format, and placement adhere to requirements throughout the product lifecycle. Ensure compliance with labeling regulations such as 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and other international guidelines.
• Establish and maintain labeling processes: Develop and maintain robust labeling processes and procedures to ensure compliance, accuracy, and consistency across product lines. This includes creation, issuance, and reconciliation. Implement control mechanisms such as document control, change management, and review cycles to maintain labeling integrity.
• Collaborate with internal stakeholders: Work closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams to ensure alignment on labeling requirements, changes, and challenges. Provide guidance and support to these teams on labeling-related matters, including artwork creation, proofreading, and version control.
• Stay informed about industry trends: Continuously monitor developments and best practices related to labeling regulations, technology, and artwork creation. Identify opportunities for process improvements, automation, and efficiency gains in labeling operations.

The essential requirements of the job include:

• 5+ years of relevant experience in drug product label/labeling required
• Experience with labeling equipment qualification and labeling process validation preferred
• Bachelor’s Degree required; life science-related field preferred
• Track record of compliance in the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Strong foundational knowledge in FDA and EU regulations specific to labels and labeling, such as 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and international guidelines

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Join our winning team today

Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges—architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.

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Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We value diversity and the existence of similarities and differences—both visible and not—found in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.

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