Suitable for: Regulatory Affairs Officer, RA Officer, Regulatory Affairs Associate, RA Associate, Regulatory Affairs Specialist, RA Specialist, Regulatory Submissions Associate, Regulatory Submissions Officer, Regulatory Submissions Specialist, Regulatory Affairs Junior Manager, RA Junior Manager, Study Start Up Officer, Study Start Up Associate, Study Start Up Specialist
We are a leading, growing and specialised Pharmaceutical company based in Munich, looking to expand our team with an experienced RA Officer who has an interest in Immunotherapy.
We are a leading, European and specialised pharmaceutical organisation dedicated to allergy treatment. Rapidly developing, with state of the art products in the pipeline, the company is growing yet increasingly. As an industry leader, we are value-driven and take pride in our innovative and sustainable approach that allows us to directly provide long term solutions to our customers.
• Set-up and submissions of high quality Reg Dossiers for new submissions
• Set up CTA /IND submissions und management of documentation
• Set-up and maintenance of product info
• Processing and filing of state batch release
• Ensuring compliance with current regulatory legislation
• Set-up change controls, impact assessments and SOPs
• Communication with admissions committee
• At least 2 years of relevant experience in the Pharmaceutical Industry with focus on Regulatory Affairs or Clinical Research
• Experience with CMC
• Good knowledge of regulatory processes in the European Union
• Excellent communication and problem solving skills
• Fluency in German and English
Please contact Sita Fox on +49 304 0817 2730 or email firstname.lastname@example.org if you would like to know more about this opportunity. This will be 100% confidential.
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