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Regulatory Administrator

Company Name:
ALKU
Environment:
This client is in the bio arena and makes innovative therapies. They are a smaller organization and need a regulatory affairs administrator to help with regulatory task as well as a handful of administrative tasks to make sure deliverable and initiatives remain organized.

Principle Duties and Responsibilities:
The consultant will be responsible for dealing with a handful of administrative tasks. While they will be using their regulatory expertise, they will be expected to handle admin tasks for the team. This will be someone with a regulatory background. They will be involved in reviewing documents, working with directors and managers as well. If they have any biologic background as well, that would be a huge plus (specifically gene therapy/innovative therapy). They could be reviewing QC documents as well as they come through. They could be looking at approved products and writing summary reports for why the product was approved. This will be someone who is extremely organized, hardworking, and who has excellent communication/writing skills. Specifically, they will be involved on the regulatory intelligence side. They need to understand regulatory from a broad standpoint and be comfortable with the admin tasks that will come along with joining a smaller team.

Required:
- 1-2+ Years Regulatory
- Administrative Tasks - Organized
- Regulatory (Affairs/Intelligence)
- Document Review
Plus:
- Biologics
- Innovative Therapy (Cell Gene)
- QC Documentation Review





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