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CMC Regulatory Affairs Manager

Sosu-job i Nordsjælland

Do you want to work on a high-profile project as the main RA responsible? Then this job as CMC Regulatory Affairs Manager might be the job for you.

Improving health & quality of life

At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you will share this mission with us.

Experienced and dedicated colleagues

In Global Regulatory Affairs we are 14 employees. You will be a part of an ambitious CMC team consisting of 5 employees and will be reporting to the Senior Director of the CMC team. In the CMC team 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).

Leading and coordinating RA programs for new facility

As CMC Regulatory Affairs Manager you are responsible for leading and coordinating programs and project initiatives for our new large-scale Fill and Finish facility. You lead the regulatory submission strategy, identify submission risks and opportunities, lead regulatory applications and manage procedures through approval. You provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams and across regulatory region...

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