Regulatory Affairs Specialist
Job Description
<p>In <strong>Elixir Pharma</strong>, we believe in every person’s right to medicine, and we also seek to improve people’s lives beyond medical treatment. Through communication, we aim to build a platform that cares for people on both; physical and mental levels.</p><p>We are young and dedicated team who are passionate to follow our dream to make an impact and build our unique success. We adopt and live our Values which are; High Quality Operations, Patient Centricity, Passion for Excellence, Respect and Integrity.</p><p>https://elixirpharma-eg.com/</p><p><strong> </strong></p><p><strong>About the Job:</strong></p><p><strong>Elixir Pharma is currently seeking to hire “Regulatory Affairs Specialist” position. The RA Specialist handles the products registration, renewal or variation process within the area of responsibility. S/He will coordinate with internal and external parties to assure efficient handling of regulatory requirements as per governmental guidelines.</strong></p><p><strong> </strong></p><p><strong>Brief Job Duties:</strong></p><ul><li><strong>Build and maintain a positive relationship within the health governmental authorities to manage the products’ registration lifecycle.</strong></li><li><strong>Identify, prepare and submit New Product dossiers/files to the Egyptian Drug Authority “EDA” as per the legislative guidelines.</strong></li><li><strong>Handle the re-registration process of products licenses.</strong></li><li><strong>Review all technical documents received from different internal departments to fulfils the legislative requirements.</strong></li><li><strong>Handle the products analysis or variation with the concerned governmental health authorities.</strong></li><li><strong>Manage audits, regulatory agency inspections, or product recalls.</strong></li><li><strong>Keeping up to date knowledge of changes in regulatory legislation and guidelines.</strong></li><li><strong>Prompt and proper response for all queries & deficiencies of submitted documents and ensures timely submission of all additionally requested documentation.</strong></li><li><strong>Assure timely delivery of activity reports on regular basis.</strong></li></ul><p> </p><p> </p><p><strong>Job Requirements:</strong></p><ul><li><strong>Bachelor’s degree in Pharmacy.</strong></li><li><strong>+2 year of experience in the similar position in Pharmaceutical company.</strong></li><li><strong>Good understanding of products’ files preparation and submission process.</strong></li><li><strong>Excellent oral and written communication and presentation skills.</strong></li><li><strong>Good command of English.</strong></li><li><strong>Initiative, Hard Worker and Team Player.</strong></li><li><strong>Proficient computer skills including MS Office Applications.</strong></li><li><strong>Organized, attention to details and promotes quality work.</strong></li><li><strong>Multi-tasking skills and work both independently and as part of a team.</strong></li></ul><p> </p><p>To apply: hr@elixirpharma-eg.com (Email Subject: Regulatory Affairs Sp. – “Candidate Name”)</p>
