Regulatory Affairs Specialist

SciPro are currently supporting a German Biotechnology company with their search for an RA Consultant to join them on an initial 12 month contract. This is a hybrid role, with 1-2 days in the office every other 2 weeks in North Rhine-Westphalia.English speaking is essential for this role, and German speaking is a strong plus.A brief summary of what they are looking for is below:Experience with CAR-T therapies and other ATMP biologicalsAbility to write IMPDs (Investigational Medicinal Product Dossiers)Experience preparing regulatory briefing materials, including Scientific Advice briefing booksStrong focus on CMC (Chemistry, Manufacturing & Controls); less emphasis on clinical activitiesHands-on MAA (Marketing Authorization Application) experienceAbility to support and draft responses to health authoritiesPlease apply within if you feely you fit the above requirements, or alternatively you can email me on e.lentell@sciproglobal.com with a copy of your CV.