Regulatory affairs manager cmc (hybrid) - united kingdom, abingdon, oxfordshire

hobson prior are currently seeking for a regulatory affairs manager cmc to join a brilliant biotech establishment on a contract basis located in abingdon with hybrid working available. our client is focused on producing novel remedies for life-threatening diseases. please note that to be considered for this role you must have the right to work in this location. key responsibilities: for this role, you will be organising the preparation of replies to cmc queries from regulatory bodies. keep an updated consciousness of cmc regulatory needs for suitable territories and communicate crucial intelligence to the establishment in a timely manner. to deliver the cmc components for marketing applications, variations, and renewals, you will collaborate with pharmaceutical development, manufacturing, qa and external associates. organise the preparation of high-quality cmc documents to assist in regulatory proposals in global areas such as asia, latin america, middle east, eastern europe and africa. requirements: familiarity with regulatory affairs as well as know-how of regulatory needs, which involves ich and regional needs. able to plan and complete cmc regulatory dossiers and handle the current upkeep of present product licenses. proficient with regulatory documentation and proposal management systems. interpersonal and communication skills both verbally and in writing. an organised individual with the ability to work on various projects simultaneously and meet deadlines. apply now : if you are interested in learning more or applying to this exciting opportunity then please click "apply" and upload a copy of your cv. alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "contact me" at the top of this page. hobson prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. hobson prior is acting as an employment agency in relation to this vacancy.

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