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Regulatory Affairs Manager - Essex - European Role, Essex



Essex, United Kingdom 

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€40,000.00 - €45,000.00

EU work permit required:


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Job Description:

A full time permanent position has arisen within European Regulatory Affairs. You must be able to perform the necessary regulatory tasks; registration strategy, dossier compilation, data and documentation review, submission execution, evaluation review Ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment. • Track and monitor queries/deficiency letters/commitments from/to Regulatory Agency to ensure these are implemented and conformed to, timely. • Develop and maintain thorough and up-to-date understanding of the EU regulatory environment. • Provide regulatory support to project teams, stakeholders and customers, as required. • Guide other RA colleagues and COREx counterparts to continually improve and grow in both technical and soft skills needed for RA work in PGT environment. • Identify process gaps in the RA operations and institute the necessary processes (SOPs, WIs) for remediation and improvement. Main Responsibilities; • Lead the registration process for new Marketing Authorisation Applications • Provide initial and final regulatory strategies in accordance with COREx processes • Contribute to strategic decisions requiring regulatory input to minimise risks • Lead the maintenance work on launch critical post-approval variations for authorised products • Provide central RA support to countries and regions • Provide RA support to new initiatives • Identify needs for new SOPs / WIs to improve processes

Job Requirements:

oA degree (or equivalent) in a Life Sciences or Pharmacy related subject oExperience working within Regulatory Affairs, including demonstrated practical experience of European submission procedures. Experience in the respiratory therapeutic area would be an advantage oA detailed understanding of European regulatory requirements and guidelines oPrevious CMC experience (or a demonstrated technical aptitude) and the ability to understand and critically evaluate the scientific content of Marketing Authorisation Applications oExperience and in-depth knowledge of the eCTD oExcellent written and verbal communication skills are kay, as is a proven track record of effectively coordinating resource and working under pressure to meet tight deadlines To apply or to find out more details please Call Emma on 01727 817 646 or Email me erussell@keypeople.co.uk
Company Info
Key People
Catherine House
St Albans, United Kingdom
Phone: 441727811634
Web Site: www.keypeople.co.uk
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