A leading international Clinical Research Organisation working in the pharmaceutical, medical device and biotechnology industry, is looking for a senior regulatory affairs consultant to join their expert ranks. Here is an opportunity to be involved in helping the launch of some of the worlds most ground breaking drugs and devices, helping patients worldwide to get the treatments they need.

If you are interested in working for a company with the ability to make a difference globally, then read on to see how your expertise can make a difference:

? Manage and lead the regulatory staff providing technical and strategic information and advice.
? Review and analyse CMC documentation and prepare regulatory strategy documents using specialised expert knowledge.
? Handle the preparation and submission of quality sections of regulatory applications.
? Liaise with clients, internal staff, regulatory authorities and potential clients regularly.
? New business generation.
? Identify and initiate management of departmental improvements.

Skills and Qualifications

? Degree or equivalent in scientific/technical discipline.
? Experience of regulatory affairs with working experience of preparation and/or assessment of biotech and biological products.
? Experience of preparation of pharmaceutical quality (CMC) documentation.
? Proven ability to interact with clients, regulatory bodies and colleagues in preparing the relevant documentation.
? MUST be fluent in German.

This company is looking for confident, experienced regulatory specialists with excellent interpersonal skills to join their team in Germany. If you are enthusiastic, able to prioritise workloads and enjoy working as part of a matrix environment, then this could be the opportunity you are looking for.

They are a long established company, with fantastic opportunities to make a real difference to biological advancement and in turn, peoples lives and well-being. Their vision is to continue to provide an expert service to all their clients and thus contribute to cure and prevent disease by helping to develop the technology to make this possible.

For more information regarding this role, please contact Katy Bloom at Paramount Recruitment on 0121 616 5037.
Location
Germany, Freiburg


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