Regulatory Affairs AssociateThe 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 listings • Providing general regulatory advice to company's staffBased in the UK, the Regulatory Affairs Associate is expected to; • 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, • Obtain approval for clinical trials,• 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 skills