Everyone achieves greatness at BioNTech! That’s because, as the largest privately held biotechnology company in Europe, we are working on revolutionary approaches in the fight against cancer and other diseases. Over 800 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!
Regulatory Affairs Strategist (m/f)
Global Regulatory Affairs
Here, you’ll achieve greatness.At BioNTech, you will play a central role at the interface between manufacturing, non-clinical, clinic, medical device - entering new ground in the field of regulatory requirements for individualized immunotherapies. Your duties in detail:
- Conduct of interactions with national authorities and international agencies (e.g. MPA, PEI, EMA, FDA and WHO) in the scope of product development and market authorisation
- Performance of regulatory activties in preparation of market authorisation incl. compiling of MAA/BLA dossier in the areas Europe and US
- Regulatory Intelligence: Monitoring changes and evolution of regulatory landscape for both drug and medical devices. Analyzing the impact of drug/devices changing regulations for BioNTech's products
What you have to offer.
- Degree in natural sciences or regulatory affairs or comparable studies. An additional degree in regulatory affairs or comparable studies is advantageous. Degree with a doctorate in natural sciences or medicine would be beneficial
- At least 8 years of professional experience in the field of regulatory affairs in the US
- Experience in the field of biologics and ATMPs in clinical development. Experience in MAA/BLA preparation is a plus
- Very good knowledge of the relevant laws and guidelines
- Fluent proficiency in spoken and written English
Benefits for you.
Have we kindled your pioneering spirit?Then apply now for our location Mainz and simply send us your application documents using our online form.
If you have any further questions, Friederike Mangelsen will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).