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Regulatory Affairs Specialist
1 month ago
Job Description
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
Qualifications:
Qualifications
• 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
Additional Information
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Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.
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Excellent full time benefits including comprehensive medical coverage, dental, and vision options
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Life and disability insurance
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401(k) with company match
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Paid vacation and holidays
Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
