Global Dx Regulatory Affairs Coordinator at Eurofins Lancaster Laboratories Professional Scientific Services, LLC in Kalamazoo, Michigan

Job Description:

Company Description



The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.


Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.


If you're looking for a rewarding career, apply with us today!



Job Description

• Assure accurate data entries for Human Health Products


• Collaborate with the Global Product Dictionary Admin team to assure Global Diagnostics system needs are met


• Facilitate release of product shipments within the ERP system when Regulatory approvals are obtained- Regulatory Affairs Documentation Support:


• Coordinate with Regulatory Affairs Managers and Manufacturing Compliance Members to obtain legalization of documents required for International Markets


• Gather manufacturing documents and other documents needed to support registration as requested by the regulatory team


• Upload required documents into the Enterprise-wide Document Management System


• Maintains information systems (electronic and paper) for regulatory information- Assist in the development of instructional guidance's and processes, as applicable - Provide status updates on tasks as appropriate


• Label Backup Support (in support of the primary diagnostic label lead):


• Liaise with Regulatory Affairs managers, icRAMS and the Client Artwork Center to assure compliance with global diagnostics labelling requirements


• Managestudy risk assessments process including risk assessment intake, assignment, compilation, signatures, and final archival

Qualifications

• A degree in Science, Pharmacy, or related business


• Knowledge or experience of Diagnostics products and Regulatory Affairs preferred.


• At least one year experience working in Veterinary / Human Regulatory Affairs environment.


• Experience working in a dynamic multicultural environment and working with colleagues based in multiple countries.

Additional Information



Position is full-time, first shift, Monday-Friday 8AM-5PM.Candidates currently living within a commutable distance ofKalamazoo, MIare encouraged to apply.



What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options


• Life and disability insurance


• 401(k) with company match


• Paid vacation and holidays


• Yearly goal-based bonus & eligibility for merit-based


• #LI-EB1

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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