Indrykket:
QA Mammalian Scientist
AGC Biologics A/S
Jobannonce: Senior Specialist, Regulatory Affairs
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Orifarm, Hobro, Odense, Skælskør eller Søborg
As Senior Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.
Further, your main responsibilities include to:
- Gather information and documentation for variation applications
- Update dossier sections
- Prepare variation applications and response
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