Regulatory Affairs
Regulatory Affairs CMC Manager
Summary
Leads global CMC regulatory strategies and submissions for vaccines, with a primary focus on expanding a chikungunya vaccine into new markets and supporting its lifecycle.
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Opportunity summary
Employment type: Full time. Remote: Hybrid. Requisition: JR101538. Country: Denmark.
Are you passionate about regulatory affairs and bringing innovative vaccines to patients worldwide? Would you like to shape global CMC strategies and support the expansion of our life-saving vaccines? Then you could be our next Regulatory Affairs CMC Manager. At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system.
Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, cholera, and chikungunya. We excel in R&D innovation, manufacturing, and commercialization, striving to improve people's health and quality of life worldwide while protecting our tomorrow.
The role
Your primary focus will be the continued global expansion of our chikungunya vaccine following its initial approvals in the US and Europe. You will play an important role in shaping the regulatory approach for new markets and supporting the vaccine throughout its lifecycle.
Working across R&D and Global Operations, you will provide clear regulatory direction, coordinate activities across functions, and help move complex regulatory priorities forward. As Regulatory Affairs CMC Manager, you will join a skilled team of three colleagues responsible for global CMC regulatory activities1 …
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