Specialist in Regulatory Affairs - Askov, MN, United States - Cascade Enterprises
Description
Job Description:
Our team of researchers are the creative minds behind our new developments. They identify the individual steps in the mechanisms of a disease or condition that could be prevented or improved. Our goal is to develop a treatment that proves effective in treating a disease.
With innovative thinking, state-of-the-art facilities, and solid scientific methods, we work together to develop the next groundbreaking innovation in medicine.
We are currently seeking a full-time, permanentSpecialist Regulatory Affairs (m/f/d) for our innovative research location in Askov, MN.
As part of our global Regulatory Affairs team, you will support cross-functional processes and activities.
Your Responsibilities:
- Creation and maintenance of document templates for registration dossiers, change notifications, statements, etc.
- Active maintenance of the internal manual of the global regulatory department
- Tracking the status of global submissions with a focus on international markets and maintaining related regulatory systems
- Assisting with coordination of incoming inquiries through the central inbox
- Supporting the procurement of necessary documentation from manufacturing sites and other global functions for the preparation of change notifications or registration dossiers
- Processing administrative (regulatory) inquiries or requests for administrative documents to support international approvals
- Assisting with the onboarding of new colleagues
- Collecting and maintaining regulatory information, taking into account related processes, and maintaining relevant systems and databases
Your Profile:
- Bachelor's degree in a scientific field or completed training as a veterinary assistant, medical laboratory technician,
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