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Regulatory Affairs Specialist

Job in Kalamazoo - Kalamazoo County - MI Michigan - USA , 49001
Full Time position
Listed on 2021-04-12
Job specializations:
  • Science
    Life Science
  • Pharmaceutical
Job Description & How to Apply Below
Position:  International Regulatory Affairs Specialist
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.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

The Regulatory Affairs Specialist provides document assistance to support the team in obtaining registrations for company products, monitors and analyzes document request workload and provides solutions for continuous improvement.

Essential Duties and Responsibilities:

Assist the team in the following activities:

* Prepare applications for official certificates and related official and administrative documents to support regulatory processes.
* Official certificates (USDA and FDA primarily)
* Letters of authorization
* Other administrative documents generated by the team
* Coordinate legalization processes for official certificates and related documents to support submissions.
* Act as the group Public Notary.
* Maintain SharePoint Site Request System:
* Generate metrics to assess workload and workflow efficiency
* Generate monthly reports to monitor and analyze document request workflow, identify issues and propose solutions
* Liaise with BT to update the system (workflows, users and routings, troubleshooting, etc.)
* Build and provide technical support for dossier binder creation in Veeva Vault:
* Create binders in Veeva Vault for dossier compilation as requested by team members
* Locate technical files for dossier compilation in Veeva Vault
* Liaise with BT for Veeva Vault maintenance or changes to binders as requested by team members
* Maintain SharePoint Site for regulatory requirements
* Bachelor's Degree on any scientific field with proficiency in biology or animal health technical terms.
* Team worker, self-motivated proactive behavior;
* Attention to detail;
* Able to perform assigned responsibilities with minimal supervision;
* Able to follow and comply with company procedures;
* Able to perform and document work following applicable established methods, SOP's, official regulations and guidelines

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.

* 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

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

I'm interested
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