CMC Regulatory Affairs Senior Manager

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CMC Regulatory Affairs Senior Manager

Kvistgård

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Do you want to influence Bavarian Nordic’s product development towards regulatory approvals, then this might be the job for you!

You will be a part of an ambitious Regulatory Affairs CMC team consisting of eight employees and two CMC Contractors and you will report to the Senior Director RA CMC.

The Regulatory Affairs CMC team is responsible for regulatory matters related to both new drug developments and life cycle management of registered products. We are responsible for writing the quality sections for IND/CTA and BLA/MAA applications and for answering technical requests from the Health Authorities (e.g., FDA, EMA, Health Canada). RA CMC is part of the global Regulatory Affairs team.