Specialist in Regulatory Affairs - Askov, MN, United States - Cascade Enterprises

James Miller

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James Miller

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Freelance
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, permanent
Specialist 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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