Regulatory Affairs Associate

The Regulatory Affairs Associate will be responsible for:• Managing the clinical trial applications in Europe and other selected countries• Keeping up to date with regulatory and legal changes in EU• Preparing pre- and post-authorisation regulatory documentation and applications• Assisting in marketing access activities including
pricing/contracts/product
listingsDESCRIPTION OF THE ROLE• Prepare and/or collate all documentation to support clinical trial applications in Europe and other selected countries in close cooperation with the Clinical department,• Submit applications to competent authorities and ethics committees in Europe and other selected countries,• Prepare responses to questions raised by ethics committees and competent authorities and update documentation as required,• Manage the labelling of investigational medicinal product in compliance with regulatory labelling requirements,• File substantial amendments as required,• Assist with updating the Investigator Brochure and Investigational Medicinal Product Dossier.Assist in the development of the ongoing global regulatory strategy• Submissions of marketing authorisation applications and variations• Prepare response to questions raised by competent authorities• Applications and submissions to national regulatory authorities as required• Submissions following post approval obligations and commitments• Maintain all approvals current by submitting annual updates as neededESSENTIAL REQUIREMENTS FOR ROLE• Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplines.• Pharmaceutical industry experience• Preparation of clinical trial applications• High level of personal integrity and ethical behaviour• Strong attention to detail and time management• Strong written and communication skillSend me alerts about jobs like this.Please enter your email address to continue setting up an email alert for similar jobs to this one. By entering your email address and clicking apply you will sign up to Jobs4 and agree to our terms and conditions .
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